selected health provisions in title iii of the cares act

Selected Health Provisions in Title III of the

CARES Act (P.L. 116-136)

April 29, 2020

Congressional Research Service

https://crsreports.congress.gov

R46334


SUMMARY

Selected Health Provisions in Title III of the CARES Act (P.L. 116-136) The global pandemic of Coronavirus Disease 2019 (COVID-19) is affecting communities around

the world and throughout the United States, with the number of confirmed cases and fatalities

growing daily. Containment and mitigation efforts by U.S. federal, state, and local governments

have been undertaken to “flatten the curve”—that is, to slow the widespread transmission that

could overwhelm the nation’s health care system.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136; H.R. 748)

was enacted on March 27, 2020. It is the third comprehensive law enacted in 2020 to address the pandemic. In addition to a

number of broad health care provisions, the CARES Act provides additional supplemental appropriations to support federal

response efforts and authorizes a number of economic stimulus measures, among other things.

This report describes the majority of health-related sections in Division A, Title III, of the CARES Act, “Supporting

America’s Health Care System in the Fight Against the Coronavirus.” Relevant background is provided for context.

Specifically, this report describes provisions regarding, among other things, the following:

The availability of medical countermeasures (MCMs)—drugs, tests, treatments, medical devices, and

supplies such as personal protective equipment (PPE)—including research and development; product

regulation by the Food and Drug Administration (FDA); the Strategic National Stockpile (SNS); and other

supply chain matters.

The health workforce, including telehealth programs, the rural health care system, and the Commissioned

Corps of the U.S. Public Health Service (USPHS). Additional workforce provisions described in this report

include reauthorization and extension of appropriations for existing HHS health workforce programs, and

liability limitation.

Provisions addressed at the Medicare and Medicaid programs and on private health insurance plans that

temporarily require, or increase payment for, telehealth services and specified services related to COVID-

19 testing, diagnosis, or treatment.

A newly established FDA authority for over-the-counter (OTC) drug review.

This report does not address education or labor provisions in Subtitle B or C in Part IV of Title III, or provisions in Subtitle E

of Part IV of Title III, “Health and Human Services Extenders,” which are described in other CRS reports. The report also

does not include Division B of the act, which provides emergency supplemental appropriations for the COVID-19 response.

The Appendix catalogues deadlines, effective dates, and reporting requirements for provisions described in the report.

This report is intended to reflect the CARES Act at enactment (i.e., March 27, 2020). It does not track the law’s

implementation or funding and will not be updated.

R46334

April 29, 2020

Elayne J. Heisler, Coordinator Specialist in Health Services

Selected Health Provisions in Title III of the CARES Act (P.L. 116-136)


Contents

Introduction ..................................................................................................................................... 1

A Snapshot of CARES Act Health Provisions .......................................................................... 1 Report Contents ......................................................................................................................... 2 Definitions, Abbreviations, and Acronyms ............................................................................... 4

“Section 319” Public Health Emergency ............................................................................ 4 Additional Definitions and Acronyms ................................................................................ 4

CARES Act Health Provisions in Title III ....................................................................................... 7

Subtitle A—Health Provisions .................................................................................................. 7 Part I—Addressing Supply Shortages—Subpart A—Medical Product Supplies ............... 7 Subpart B—Mitigating Emergency Drug Shortages ......................................................... 10 Subpart C—Preventing Medical Device Shortages .......................................................... 12 Part II—Access to Health Care for COVID-19 Patients ................................................... 13 Subpart A—Coverage of Testing and Preventive Services ............................................... 13 Subpart B—Support for Health Care Providers ................................................................ 17 Subpart C—Miscellaneous Provisions ............................................................................. 23 Part III—Innovation .......................................................................................................... 30 Part IV—Health Care Workforce ...................................................................................... 31

Subtitle D—Finance Committee ............................................................................................. 38 Subtitle F—Over-the-Counter Drugs ...................................................................................... 55

Part I—OTC Drug Review ............................................................................................... 55 Part II—User Fees............................................................................................................. 58

Tables

Table 1. Acronyms Used in This Report .......................................................................................... 4

Table A-1. Title III CARES Act Provisions with Implementation Dates, Reporting

Requirements, and Deadlines ..................................................................................................... 61

Appendixes

Appendix. Health Provisions in Title III of the CARES Act: Implementation Dates,

Reporting Requirements, and Deadlines .................................................................................... 60

Contacts

Author Information ........................................................................................................................ 68


Congressional Research Service 1

Introduction The global pandemic of Coronavirus Disease 2019 (COVID-19) is affecting communities around

the world and throughout the United States, with the number of confirmed cases and fatalities

growing daily. Containment and mitigation efforts by U.S. federal, state, and local governments

have been undertaken to “flatten the curve”—that is, to slow the widespread transmission that

could overwhelm the nation’s health care system.1

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act, P.L. 116-136) was

enacted on March 27, 2020. It is the third comprehensive law to address the pandemic. In

addition to its health provisions, the CARES Act provides additional supplemental appropriations

to support federal response efforts and authorizes a number of economic stimulus measures,

among other things.

The CARES Act follows two other laws that made supplemental appropriations and amended

health care financing and public health authorities to respond to the pandemic. The first, the

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123),

enacted on March 6, 2020, provides roughly $7.8 billion in discretionary supplemental

appropriations to the Department of Health and Human Services (HHS), the Department of State,

and the Small Business Administration.2 This act also waives certain telehealth restrictions to

make telehealth services more available during the emergency.3 The second, the Families First

Coronavirus Response Act (FFCRA, P.L. 116-127), enacted on March 18, 2020, provides

authority, funding, and/or requirements to cover COVID-19 testing and related services under

federal programs, many private health insurance plans, and for the uninsured (as defined in the

act). Among other provisions, it temporarily increases the federal share of Medicaid assistance to

states, provides additional Medicaid assistance to territories, and waives liability and establishes

injury compensation for certain respiratory protection devices.4

A Snapshot of CARES Act Health Provisions

Medical supply shortages. The COVID-19 pandemic has affected the medical product supply

chain both globally and domestically, resulting in widespread shortages of medical

countermeasures (MCMs) and other critical medical supplies. MCMs are medical products that

may be used to treat, prevent, or diagnose conditions associated with emerging infectious diseases

or chemical, biological, radiological, or nuclear threats. Examples of MCMs include biologics

(e.g., vaccines), drugs (e.g., antivirals), and devices (e.g., diagnostic tests and personal protective

equipment, or PPE).

The CARES Act includes several provisions to address such shortages, including expanding

reporting requirements for firms that experience interruptions in drug and device manufacturing;

explicitly requiring that the Strategic National Stockpile (SNS) contain PPE, ancillary medical

supplies, and other applicable supplies; and extending liability protections for certain respiratory

protective devices used during emergencies. The CARES Act also requires a study of U.S.

1 For an overview of domestic Coronavirus Disease 2019 (COVID-19) health response efforts and a compilation of

federal agency websites, see CRS Insight IN11253, Domestic Public Health Response to COVID-19: Current Status.

2 CRS Report R46285, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-

123): First Coronavirus Supplemental; and CRS Insight IN11236, Oversight Provisions in H.R. 6074, the Coronavirus

Preparedness and Response Supplemental Appropriations Act.

3 CRS Report R46239, Telehealth and Telemedicine: Frequently Asked Questions.

4 CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127.



dependence on critical drugs and medical devices imported from or manufactured in other

countries.

Vaccine access and cost. A vaccine(s) for the COVID-19 virus, if and when it becomes available,

will be provided or required to be covered without cost-sharing to patients and beneficiaries of

federal health programs and most private health insurance enrollees, pursuant to numerous

provisions in Division A, Title III, of the CARES Act. The CARES Act does not explicitly

address vaccine access for the uninsured. However, with available appropriations and preexisting

authorities, the HHS Secretary could assist safety net providers (e.g., health centers), health

departments, and other entities in furnishing vaccines to this population.

The medical workforce. The CARES Act makes a number of changes to health workforce

programs. Some changes aim to extend the services available during the COVID-19 period and

beyond, particularly for rural or otherwise underserved populations. For example, the CARES Act

confers medical malpractice liability on health professionals who choose to volunteer during the

emergency period and amends the program rules for the National Health Service Corps (NHSC)

program to permit individuals to volunteer during the emergency period. The CARES Act also

reauthorizes a number of health workforce programs that had been considered for reauthorization

during the 116th Congress, but prior to the CARES Act no reauthorization of these programs was

enacted.

Marketing of over-the-counter drugs. The CARES Act establishes a new process for the

marketing of certain over-the-counter (OTC) drugs, including hand sanitizer and sunscreen.

Specifically, Title III replaces the current OTC drug monograph rulemaking process with an

administrative order process—a less burdensome alternative. It also provides an expedited

process for removing from the market certain OTC drugs that pose a public health hazard and for

requiring certain safety labeling changes. The CARES Act provides an incentive—18 months of

marketing exclusivity—to firms that make certain changes to previously marketed OTC drugs

and creates a new user fee program to fund FDA’s OTC monograph drug activities.

Report Contents

This report describes the majority of health-related sections in Division A, Title III of the CARES

Act, “Supporting America’s Health Care System in the Fight Against the Coronavirus.” Relevant

background is provided for context. Specifically, this report describes provisions regarding,

among other things the following:

The medical countermeasures (MCMs)—drugs, tests, treatments, medical

devices, and supplies such as PPE—including research and development; product

regulation by the Food and Drug Administration (FDA); the strategic national

stockpile (SNS); and other supply chain matters.

The health workforce, including telehealth programs, the rural health care

system, and the Commissioned Corps of the U.S. Public Health Service

(USPHS). Additional workforce provisions described in this report include

reauthorization and extension of appropriations for existing Health and Human

Services (HHS) health workforce programs, and liability limitation.

Provisions addressed at the Medicare and Medicaid programs and on private

health insurance plans to temporarily require, or increase payment for, telehealth

services and specified services related to COVID-19 testing, diagnosis, or

treatment.

A newly established FDA authority for OTC drug review.



This report does not address education or labor provisions in Subtitle B or C in Part IV of Title

III, 5 or provisions in Subtitle E of Part IV of Title III, “Health and Human Services Extenders,”

which are described in another CRS report.6 The report also does not include Division B of the

act, which provides emergency supplemental appropriations for the COVID-19 response.

Division B includes additional funding for numerous HHS public health and social services

activities, and a $100 billion fund to reimburse eligible health care providers for health care-

related expenses or lost revenues attributable to COVID-19.7 This report concludes with an

Appendix that catalogues deadlines, effective dates, and reporting requirements for provisions

described in the report.

The report does not discuss cost estimates for specific provisions; however, the Congressional

Budget Office (CBO) and the Joint Committee on Taxation (JCT) provided a preliminary estimate

of the budget effects of the CARES Act.8 Overall, the act is estimated to increase federal deficits

by $1.8 trillion over the 2020-2030 period. This estimate breaks down these budgetary effects

into three categories: a $988 billion increase in mandatory outlays; a $446 billion decrease in

revenues; and a $326 billion increase in discretionary outlays from supplemental appropriations.

The estimates that CBO generated for health programs in Title III include programs in Subtitle E

of Part IV of Title III, “Health and Human Services Extenders,” which are not discussed in this

report. Among the provisions discussed in this report, JCT estimates that Section 3702, which

expands the products that are eligible for tax-advantaged distributions from health savings

accounts (HSAs), health flexible spending arrangements (FSAs), and other similar tax-

advantaged savings arrangements, will reduce revenues by $9 billion over a ten-year period from

2020-2030. CBO also estimated the costs of a number of Medicare payment changes included in

CARES Sections 3701-3715. These provisions generally increase the amount that Medicare will

reimburse for services; as such, CBO estimates that they will increase Medicare spending from

2020-2030. CBO also noted that some provisions—e.g., the requirement for Medicare to cover

the costs of vaccines for COVID-19—cannot be estimated because no such vaccine has been

developed at this time. In general, these CBO estimates are based on assumptions about the

severity and duration of the pandemic, and they may vary substantially from final estimates to be

provided later this year.

This report is intended to reflect the CARES Act at enactment (i.e., March 27, 2020). It does not

track the law’s implementation or funding and will not be updated. This report is one of a number

of CRS reports related to COVID-19; additional CRS products on COVID-19 are available at

https://www.crs.gov/resources/coronavirus-disease-2019.

5 Education provisions are described in CRS In Focus IF11497, CARES Act Higher Education Provisions, and CRS In

Focus IF11509, CARES Act Elementary and Secondary Education Provisions.

6 CRS Report R46331, Health Care-Related Expiring Provisions of the 116th Congress, Second Session.

7 For more information on the new fund, see U.S. Department of Health and Human Services (HHS), “CARES Act

Provider Relief Fund,” April 13, 2020, https://www.hhs.gov/provider-relief/index.html. The Paycheck Protection

Program and Health Care Enhancement Act enacted on April 24, 2020 (P.L. 116-139) appropriated an additional $75

billion to the CARES Act Provider Relief Fund and provided an additional $25 billion to HHS for COVID-19 testing.

See CRS Report R46325, Fourth COVID-19 Relief Package (P.L. 116-139): In Brief.

8 For the complete preliminary cost estimate, see Congressional Budget Office, “Letter from Phillip L. Swagel,

Director, Congressional Budget Office, to Honorable Mike B. Enzi, Chairman Senate Committee the Budget, U.S.

Senate, April 16, 2020, https://www.cbo.gov/system/files/2020-04/hr748.pdf.



Definitions, Abbreviations, and Acronyms

“Section 319” Public Health Emergency

Numerous provisions in the CARES Act refer to the Public Health Emergency declaration made

pursuant to Section 319 of the Public Health Service Act (PHSA). The “Section 319” authority

allows the HHS Secretary to carry out a specified set of actions to address public health

emergencies, such as expediting or waiving certain administrative requirements that would

otherwise apply to federal activities or federally administered grants.9 Some provisions refer to

“the emergency period declared under section 319” or similar construction, meaning the time

during which a Section 319 declaration is in effect. The declaration for COVID-19 was made on

January 31, 2020, retroactive to January 27, 2020. It is in effect for 90 days and is expected to be

renewed and remain in effect for the duration of the response.10

Several provisions in Title III, Subtitle D, regarding health care financing and amending the

Social Security Act (SSA), refer to “the emergency period described in section 1135(g)(1)(B)” or

comparable construction. Section 1135 allows the HHS Secretary, under certain conditions, to

waive specified requirements and regulations to ensure that health care items and services are

available to enrollees in the Medicare, Medicaid, and State Children’s Health Insurance Program

(CHIP) programs during emergencies.11 Paragraph (1)(B) of SSA Section 1135(g) refers

specifically to “the public health emergency declared with respect to the COVID-19 outbreak by

the Secretary on January 31, 2020, pursuant to section 319 of the [PHSA],” and any renewal of

such declaration.12 Hence, these references to SSA Section 1135(g)(1)(B) simply mean the period

during which the Section 319 public health emergency declaration for COVID-19—whether

initial or renewed—is in effect.

Additional Definitions and Acronyms

Throughout this report, unless otherwise stated, the “Secretary” means the HHS Secretary.

Mentions of “this section” refer to matters addressed under that specific section of the CARES

Act. This report uses a number of acronyms, listed in the table below.

Table 1. Acronyms Used in This Report

Acronyms Definition

AAA Area Agency on Aging

ACA Patient Protection and Affordable Care Act (P.L. 111-148, as amended)

ACIP Advisory Committee on Immunization Practices

ACL Administration for Community Living

9 42 U.S.C. §247d. For more information, see HHS, “Public Health Emergency Declaration,” https://www.phe.gov/

Preparedness/legal/Pages/phedeclaration.aspx.

10 HHS, “Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel

Coronavirus,” January 31, 2020, https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. An

emergency determination under Section 319 terminates after 90 days, unless terminated earlier by the HHS Secretary,

and is renewable for additional 90-day periods. Section 319 emergencies declared in response to the 2009 H1N1

influenza pandemic and the 2016-2017 Zika virus outbreak were each renewed several times.

11 For more information, see CRS Legal Sidebar LSB10430, Section 1135 Waivers and COVID-19: An Overview.

12 This amendment to Section 1135 was made by the Coronavirus Preparedness and Response Supplemental

Appropriations Act, 2020, P.L. 116-123, div. B, §102(a)(1), (2), (b), March 6, 2020, 134 Stat. 156.



Acronyms Definition

ANDA Abbreviated New Drug Application

API Active Pharmaceutical Ingredient

ASPR Assistant Secretary for Preparedness and Response

BA Business Associate

BARDA Biomedical Advanced Research and Development Authority

BBA 2018 Bipartisan Budget Act of 2018 (P.L. 115-23)

BBEDCA Balanced Budget and Emergency Deficit Control Act of 1985 (P.L. 99-177)

BCA Budget Control Act of 2011 (P.L. 112-25)

CAH Critical Access Hospital

CARES Act Coronavirus Aid, Relief, and Economic Security Act (P.L. 116-136)

CBO Congressional Budget Office

CDC Centers for Disease Control and Prevention

C.F.R. Code of Federal Regulations

CHIP State Children’s Health Insurance Program

CLFS Clinical Laboratory Fee Schedule

CMS Centers for Medicare & Medicaid Services

COGME Council on Graduate Medical Education

COVID-19 Coronavirus Disease 2019

CPI Consumer Price Index

CRS Congressional Research Service

CSEOA Community Service Employment for Older Americans Program

DME Durable Medical Equipment

DMEPOS Durable Medical Equipment, Prosthetics, Orthotics and Supplies

DOL Department of Labor

DRI Dietary Reference Intakes

EPA Environmental Protection Agency

ESRD End-stage Renal Disease

EUA Emergency Use Authorization

FDA Food and Drug Administration

FEHBP Federal Employees Health Benefits Program

FFCRA Families First Coronavirus Response Act (P.L. 116-127)

FFDCA Federal Food, Drug, and Cosmetic Act (P.L. 75-717, as amended)

FMAP Federal Medical Assistance Percentage

FORHP Federal Office of Rural Health Policy

FQHC Federally Qualified Health Center

FSA Flexible Spending Account

FY Fiscal Year



Acronyms Definition

GACA Geriatrics Academic Career Awards

GAO Government Accountability Office

GME Graduate Medical Education

GRASE Generally Recognized as Safe and Effective

GWEP Geriatrics Workforce Enhancement Program

HBV Hepatitis Virus B

HCBS Home and Community-based Services

HDHP High-deductible Health Plan

HHS Department of Health and Human Services

HIPAA Health Insurance Portability and Accountability Act (P.L. 104-191, as amended)

HPSA Health Professional Shortage Area

HRA Health Reimbursement Arrangement

HRSA Health Resources and Services Administration

HSA Health Savings Account

IHS Indian Health Service

IMR Infant Mortality Rate

IPPS Inpatient Prospective Payment System

IRC Internal Revenue Code

IRF Inpatient Rehabilitation Facility

IRF PPS Inpatient Rehabilitation Facility Prospective Payment System

IVD In Vitro Diagnostic

JCT Joint Committee on Taxation

LTCH Long-term Care Hospital

LTCH PPS Long-term Care Hospital Inpatient Prospective Payment System

LUPA Low-utilization Payment Adjustment

MA Medicare Advantage

MA-PD Medicare Advantage Prescription Drug Plan

MCM Medical Countermeasure

MPFS Medicare Physician Fee Schedule

MS-DRG Medicare Severity-diagnosis Related Group

MSA Medical Savings Account

MUA Medically Underserved Area

NASEM National Academies of Science, Engineering, and Medicine

NDA New Drug Application

NHSC National Health Service Corps

NIH National Institutes of Health

NIOSH National Institute for Occupational Safety and Health



Acronyms Definition

OAA Older Americans Act (P.L. 89-73, as amended)

OCR Office for Civil Rights (within the Department of Health and Human Services)

OTA Other Transaction Authority

OTC Over-The-Counter

PAMA The Protecting Access to Medicare Act (P.L. 113-93)

PDUFA Prescription Drug User Fee Act (P.L. 102-571)

PHI Protected Health Information

PHSA Public Health Service Act

PPE Personal Protective Equipment

PPS Prospective Payment System

PREP Act Public Readiness and Emergency Preparedness Act (P.L. 109-417)

RHC Rural Health Clinic

SCSEP Senior Community Service Employment Program

SG U.S. Surgeon General

SIA Sunscreen Innovation Act (P.L. 113-195)

SNS Strategic National Stockpile

SSA Social Security Act

STLDI Short-term, Limited Duration Insurance

TNGP Telehealth Network Grant Program

TRC Telehealth Resource Center

USC United States Code

USPHS U.S. Public Health Service

USPSTF U.S. Preventive Services Task Force

VPA Volunteer Protection Act of 1997 (P.L. 105-19)

CARES Act Health Provisions in Title III

Subtitle A—Health Provisions

Part I—Addressing Supply Shortages—Subpart A—Medical Product Supplies

The COVID-19 pandemic has affected the medical product supply chain both globally and

domestically. Domestically, the pandemic has highlighted existing limitations in the U.S. medical

product supply chain, including lack of transparency regarding where specific medical products

and their components are manufactured and heavy reliance on foreign countries for drugs and

medical devices. Perhaps most salient has been the impact of COVID-19 on the availability of

PPE, such as respirators for health care personnel, and other respiratory devices, such as

ventilators for patients. Although the federal government and states generally have stockpiles of

PPE and ventilators to distribute during public health emergencies, stockpiled quantities have

been insufficient to meet current needs. FDA, with other agencies, has taken various steps to



prevent and mitigate shortages of critical PPE and respiratory devices, for example, by waiving

certain regulatory requirements and by enabling access to respirators and other medical devices

that have not received agency clearance prior to marketing.

Section 3101. National Academies Report on America’s Medical Product Supply

Chain Security

Background

The extent to which the United States relies on other countries for medical products is not

completely known, but available data suggest a heavy reliance. According to FDA, as of August

2019, 72% of facilities that manufacture active pharmaceutical ingredients (APIs) and 53% of

facilities manufacturing finished drugs for the U.S. market are located outside of the United

States.13 FDA is unable to determine the volume of APIs that a specific country manufactures for

the domestic or global market. The 2019 annual report from the U.S.-China Economic and

Security Review Commission states that the United States sources 80% of its APIs from foreign

countries and has identified China as the world’s largest producer of APIs.14 Recent reports have

identified limitations in FDA’s ability to oversee foreign drug manufacturing facilities and have

indicated that FDA inspections of these facilities have decreased since 2016.15 The COVID-19

pandemic has further restricted FDA’s ability to oversee the increasingly globalized medical

product supply chain, causing FDA to postpone most foreign facility inspections until at least

May 2020.16

Provision

Section 3101 requires the Secretary, within 60 days of enactment, to enter into an agreement with

the National Academies of Science, Engineering, and Medicine (NASEM) to examine and report,

“in a manner that does not compromise national security,” on the security of the U.S. medical

product supply chain. The report must assess and evaluate U.S. dependence on critical drugs and

devices from other countries; provide recommendations (e.g., a plan to improve resiliency of the

supply chain); and address any supply vulnerabilities or potential disruptions that would

significantly affect or pose a threat to public health or national security, as appropriate. In

conducting the study and developing the report, NASEM must consider input from federal

departments and agencies and consult with stakeholders through public meetings and other forms

of engagement.

13 Food and Drug Administration (FDA), Testimony of Dr. Janet Woodcock, Director the Center for Drug Evaluation

and Research, “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program,” December 10,

2019, https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-

foreign-inspection-program-12102019.

14 2019 Report to Congress of the U.S. China Economic and Security Review Commission, 116th Congress First

Session, November 2019, Chapter 3 Section 3- “Growing U.S. Reliance on China’s Biotech and Pharmaceutical

Products,” https://www.uscc.gov/annual-report/2019-annual-report.

15 See, for example, U.S. Government Accountability Office (GAO, Preliminary Findings Indicate Persistent

Challenges with FDA Foreign Inspections, GAO-20-262T, December 10, 2019, https://www.gao.gov/products/GAO-

20-262T.

16 FDA Statement, “Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections,” March 10, 2020,

https://www.fda.gov/news-events/press-announcements/coronavirus-disease-2019-covid-19-update-foreign-

inspections.



Section 3102. Requiring the Strategic National Stockpile to Include Certain

Types of Medical Supplies

Background

The federal government maintains a supply of medicine and medical supplies to respond to a

public health emergency severe enough to deplete local supplies (e.g., hurricane, infectious

disease outbreak, or terrorist attack). This supply, known as the Strategic National Stockpile

(SNS),17 includes antibiotics, intravenous fluids, and other medical supplies such as PPE and

ventilators. In addition, the SNS contains certain medicines, such as anthrax and smallpox

vaccines and treatments that may not be otherwise available for public use. In 2019, HHS stated

the SNS contained approximately $8 billion worth of supplies.18 In FY2018, management of the

SNS transferred from the Centers for Disease Control and Prevention (CDC) to the Assistant

Secretary for Preparedness and Response (ASPR).

Provision

This section amends PHSA Section 319F-2(a)(1) to require the Secretary to maintain a stockpile

of “drugs, vaccines and other biological products, medical devices, and other supplies.” This act

further defines “other supplies” as “including PPE, ancillary medical supplies, and other

applicable supplies required for the administration of drugs, vaccines and other biological

products, medical devices, and diagnostic tests in the stockpile.” Some of these types of supplies,

such as PPE, were included in the stockpile even before enactment of this clarifying language.

Section 3103. Treatment of Respiratory Protective Devices as Covered

Countermeasures

Background

In 2005 Congress passed the Public Readiness and Emergency Preparedness Act (PREP Act, P.L.

109-417), which authorizes the federal government to waive liability (except for willful

misconduct) for manufacturers, distributors, and providers of MCMs, such as drugs and medical

supplies, needed to respond to a public health emergency.19 The act also authorizes the federal

government to establish a program to compensate eligible individuals who suffer injuries from

administration or use of products covered by the PREP Act’s immunity provisions.20 Section 6005

of FFCRA (P.L. 116-127) explicitly added personal respiratory protective devices used for the

COVID-19 response to the list of countermeasures covered by the PREP Act.21

17 See HHS, Assistant Secretary for Preparedness and Response (ASPR), Public Health Emergency, “Strategic National

Stockpile,” https://www.phe.gov/about/sns/Pages/default.aspx.

18 HHS, FY2021 Public Health and Social Services Emergency Fund Congressional Justification, p. 103.

19 HHS, ASPR, “Public Readiness and Emergency Preparedness Act,” https://www.phe.gov/Preparedness/legal/

prepact/Pages/default.aspx.

20 HHS, Health Resources and Services Administration (HRSA), “Countermeasures Injury Compensation Program

(CICP),” https://www.hrsa.gov/cicp/index.html.

21 For more information on respiratory protective devices, and the certification program run by the National Institute for

Occupational Safety and Health (NIOSH), see CRS In Focus IF11488, Personal Protective Equipment and Ventilators

for COVID-19: FDA Regulation and Related Activities; and the Centers for Disease Control and Prevention (CDC),

NIOSH, “National Personal Protective Technology Laboratory: About NPPTL,” https://www.cdc.gov/niosh/npptl/

about.html.



Provision

Section 3103 amends PHSA Section 317F-3 to change the definition of such covered devices to

apply more broadly, to “a respiratory protective device that is approved by the National Institute

for Occupational Safety and Health (NIOSH) under part 84 of title 42, Code of Federal

Regulations (or any successor regulations), and that the Secretary determines to be a priority for

use during a public health emergency declared under [PHSA] section 319.”22

Subpart B—Mitigating Emergency Drug Shortages

Background

Drug shortages have remained a serious and persistent public health concern, despite the

prevention and mitigation efforts of Congress, FDA, and the private sector. Causes of drug

shortages include manufacturing and quality issues, lack of transparency in the supply chain, and

business decisions made by individual firms (e.g., low profit margins leading to market exit).23

The Federal Food Drug and Cosmetic Act (FFDCA) and FDA regulations require manufacturers

of certain drugs to submit to FDA specified information related to product shortages. In addition,

the FFDCA and FDA regulations allow FDA to take action to mitigate or prevent shortages and

require FDA to make public certain information about drug shortages. More specifically, FFDCA

Section 506C(a) requires that the manufacturer of a drug that is life-supporting, life-sustaining, or

intended for use in the prevention or treatment of a debilitating disease or condition notify the

Secretary (FDA by delegation of authority) of any permanent discontinuance or interruption in

the manufacture of the drug that is likely to disrupt its U.S. supply.24 The notification must

include the reasons for the interruption or discontinuance. FFDCA Section 506C(g) allows FDA,

based on notifications received pursuant to Section 506C(a), to expedite facility inspections and

review of supplements to new drug applications (NDAs), abbreviated NDAs (ANDAs), and

supplements to ANDAs that could help mitigate or prevent a drug shortage.25 FFDCA Section

506E requires FDA to maintain a public, up-to-date list of drugs that are in shortage. The list must

include the name of the drug in shortage, the name of the manufacturer, and, as determined by

FDA, the estimated duration of and reason for the shortage.26

Persons that engage in the “manufacture, preparation, propagation, compounding or processing”

of a drug must register their facility with FDA.27 FFDCA Section 510(j) requires that at the time

of registration, such persons must file a list of all drugs being “manufactured, prepared,

propagated, compounded or processed” for commercial distribution.28

Facilities registered with FDA are subject to inspection by the agency. FFDCA Section 704(b)

requires that after a facility has been inspected, the inspector must provide a report, in writing, to

22 Of note, the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (the first supplemental

appropriation for the COVID-19 response), P.L. 116-123, and the Coronavirus Aid, Relief, and Economic Security Act

(CARES Act, P.L. 116-136) authorized the HHS Secretary to transfer unspecified amounts of appropriated funds to the

Covered Countermeasure Process Fund.

23 FDA, “Drug Shortages: Root Causes and Potential Solutions,” published October 2019 and updated February 21,

2020, https://www.fda.gov/media/131130/download.

24 21 U.S.C. §356c(a).

25 21 U.S.C. §356c(g).

26 21 U.S.C. §356e.

27 21 U.S.C. §360.

28 21 U.S.C. §360(j).



the person in charge of that facility detailing the observations that led the inspector to determine

that a product made in that facility may be adulterated. A copy of this report also must be sent to

FDA.29

Section 3111. Prioritize Reviews of Drug Applications; Incentives

Section 3111 amends FFDCA Section 506C(g) to require—rather than allow as was the case prior

to the CARES Act—FDA to prioritize and expedite—rather than expedite as prior to CARES—

facility inspections and review of ANDAs and supplements to NDAs and ANDAs that could help

mitigate or prevent a drug shortage.

Section 3112. Additional Manufacturer Reporting Requirements in Response to

Drug Shortages

Section 3112(a) amends FFDCA Section 506C(a) to extend notification requirements to the

manufacturer of any drug “that is critical to the public health during a public health emergency

declared by the Secretary” under PHSA Section 319. It also requires a manufacturer to notify

FDA of any permanent discontinuance or interruption in the manufacture of an API—not just the

finished drug—that is likely to lead to a meaningful disruption in the supply of the API of such

drug. The notification must include, in addition to the reasons for the drug’s discontinuance or

interruption, as applicable, information about the source of the API and alternative sources, as

well as whether any associated device used in the preparation or administration of the drug has

contributed to the shortage, among other information.

Section 3112(b) amends FFDCA Section 506C to add a new subsection (j). New FFDCA Section

506C(j) requires the manufacturer of a drug, API, or associated medical device subject to the

notification requirements under FFDCA Section 506C(a), as amended, to develop, maintain, and

implement a redundancy risk management plan, as appropriate. Such plan should identify and

evaluate risks to the supply of the drug, as applicable, for each facility in which the drug or API is

manufactured. The plan is subject to inspection and copying by the Secretary.

Section 3112 (c) amends FFDCA Section 506E to require the Secretary, not later than 180 days

after enactment and every 90 days thereafter, to transmit to the Centers for Medicare & Medicaid

Services (CMS) a report regarding the drugs on the current drug shortage list.

Section 3112 (d) amends FFDCA Section 704(b) to require that following the inspection of a

facility manufacturing a drug at risk of shortage or with limited competition, a copy of the

inspection report be sent “promptly” to all appropriate FDA offices with expertise in drug

shortages. Specifically, this requirement applies to the inspection of a facility manufacturing a

drug—approved under an NDA or ANDA—for which a notification has been submitted under

FFDCA Section 506C(a) (regarding an interruption in manufacturing or discontinuance), a drug

that has been on the shortage list under FFDCA Section 506E in the past five years, or a drug with

no blocking patents or exclusivities for which there are not more than three approved drugs listed

in the Orange Book.30

Section 3112(e) amends FFDCA Section 510(j) to require each drug manufacturer that registers

with FDA to report annually to the Secretary for each listed drug “the amount that was

29 21 U.S.C. §374(b).

30 The Orange Book satisfies the statutory requirement that FDA make publicly available, and revise every 30 days, a

list of drugs that have been approved for safety and effectiveness and any patent information submitted with respect to

such drugs. It also lists any unexpired periods of exclusivity covering an approved drug, in addition to other

information applicants may find helpful.



manufactured, prepared, propagated, compounded, or processed by such person for commercial

distribution.” The Secretary may require this information to be submitted in electronic format,

may require that this information be submitted at the time a public health emergency is declared

under PHSA Section 319, and may exempt certain biologics from these reporting requirements if

the Secretary determines it is not necessary to protect the public health.

Subpart C—Preventing Medical Device Shortages

Section 3121. Discontinuance or Interruption in the Production of

Medical Devices

Background

FDA regulates the safety and effectiveness of medical devices in the United States. All medical

device manufacturers are required to register their establishments with FDA,31 and such

establishments are subject to inspections by FDA personnel or representatives. In addition, most

medical devices are required to be reviewed by the agency prior to marketing; such premarket

review mechanisms include premarket notification (510(k)),32 premarket approval,33 de novo

classification request,34 and humanitarian device exemption,35 among others.

Prior to the COVID-19 outbreak, concerns arose about potential medical device shortages due to

the closure of ethylene oxide sterilization facilities that were not in compliance with U.S.

Environmental Protection Agency (EPA) standards.36 In contrast to the agency’s authority to

compel manufacturers of certain drugs to report discontinuances or interruptions in production,37

FDA did not have such authority for medical devices prior to the CARES Act. Rather, FDA relied

on manufacturers to voluntarily report such information to the agency. In its FY2021

Congressional Justification, FDA requested additional authority to “require firms to notify FDA

of an anticipated significant interruption in the supply of an essential device; require all

manufacturers of devices determined to be essential to periodically provide FDA with information

about the manufacturing capacity of the essential device(s) they manufacture; and authorize the

temporary importation of devices whose risks presented when patients and healthcare providers

lack access to critically important medical devices outweigh compliance with U.S. regulatory

standards.”38

Legislation introduced in the 116th Congress would provide FDA with additional authority to

mitigate potential device shortages, generally through adding required reporting requirements on

device manufacturers and allowing for expedited premarket review and inspections in certain

31 21 U.S.C. §360; 21 C.F.R. Part 807.

32 21 U.S.C. §360(k); 21 C.F.R. Part 807.

33 21 U.S.C. §360e; 21 C.F.R. Part 814.

34 21 U.S.C. §360c(f)(2).

35 21 U.S.C. §360j(m).

36 FDA, “Statement on concerns with medical device availability due to certain sterilization facility closures,” October

25, 2019, https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-

certain-sterilization-facility-closures.

37 21 U.S.C. §356c.

38 FDA FY2021 Justification of Estimates for Appropriations Committees, p. 36.



cases of shortage.39 However, some bills propose providing FDA with more authority than others,

such as those allowing for importation of unapproved devices in the case of a device shortage.40

Provision

Section 3121 creates a new FFDCA Section 506J, which requires medical device manufacturers

to report to FDA during or prior to a public health emergency41 any permanent discontinuance of

production, or interruption in production, likely to lead to a meaningful disruption in supply of a

medical device, including the reasons for the discontinuance or interruption. Medical device

manufacturers are required to report this information to FDA at least six months prior to

occurrence, or as soon as is practical. In turn, FDA is required to make such information public to

appropriate organizations (e.g., physicians, supply chain partners) unless such a disclosure would

adversely affect the public’s health. If a manufacturer fails to submit information about

discontinuances or interruptions, FDA is required to submit a letter to the manufacturer

documenting this failure. The manufacturer is required to respond with reasons for

noncompliance, as well as with information on interruptions or discontinuances as originally

required, within 30 days. FDA would make such information public within 45 days of receipt but

is not able to disclose to the public any information considered confidential or a trade secret.

New FFDCA Section 506J also requires FDA to establish and maintain a device shortage list that

includes, among other things, the category or name of the device in shortage and, as determined

by FDA, the reason(s) for the shortage (e.g., demand increase for the device) and the expected

duration of the shortage. Such information must be made public, except if such information is

considered confidential, a trade secret, or determined by FDA to be harmful to the public’s health

(e.g., increases the possibility of hoarding). Finally, new FFDCA Section 506J requires FDA to

expedite premarket review and facility inspections of medical devices considered to be, or likely

to be, in shortage and defines the terms “meaningful disruption” and “shortage.”

Part II—Access to Health Care for COVID-19 Patients

Subpart A—Coverage of Testing and Preventive Services

This subpart includes three provisions related to coverage of COVID-19 tests and subsequent

vaccines that may be developed to prevent COVID-19. They primarily address private health

insurance coverage, including insurer payments to providers who furnish the test. One provision

expands the FFCRA definition of testing that must be covered without cost-sharing by most

private health insurance plans, and by other public and private health coverage programs and

plans that reference the FFCRA definition.

Section 3201. Coverage of Diagnostic Testing for COVID-19

Background

Through multiple provisions in Divisions A and F, FFCRA provides payment for or requires

coverage of testing for the COVID-19 virus, and items and services associated with such testing,

39 See for example, S. 3468 (116th Congress); S. 3343 (116th Congress); H.R. 6049 (116th Congress); H.R. 6062 (116th

Congress).

40 H.R. 6062 (116th Congress).

41 See ““Section 319” Public Health Emergency”.



without any cost-sharing. 42 Several of these provisions refer to a definition for COVID-19 testing

established in FFCRA Section 6001(a)(1), which defines such tests to include in vitro diagnostics

(IVDs), as defined in FDA regulation, that detect the SARS-CoV-2 virus43 or diagnose COVID-

19 and that have received either 510(k) clearance, premarket approval, authorization pursuant to

de novo classification, or emergency use authorization (EUA) for marketing.

This definition is used or cross-referenced in the following provisions providing payment for or

requiring coverage of testing for the COVID-19 virus: (1) Section 6001(a)(1)-(2), with respect to

specified types of private health insurance coverage; (2) Section 6006, with respect to TRICARE,

veterans’ health care, and federal civilian employee health coverage (Federal Employees Health

Benefits Program or FEHBP); and (3) Section 6007, with respect to the Indian Health Service

(IHS). In addition, appropriations provided in FFCRA Division A to the Defense Health Program,

Veterans Health Administrations, IHS, and Public Health and Social Services Emergency Fund

are to be used, in whole or in part, to pay for COVID-19 testing and related services, with

reference to FFRCA Section 6001(a)(1).

On March 16, 2020, FDA updated guidance relating to COVID-19 diagnostic tests during the

public health emergency.44 In this guidance, the agency detailed four policies, whereby

manufacturers or laboratories could develop, use, or market laboratory-developed tests or test kits

for COVID-19. Two of these policies allowed for laboratories and test kit manufacturers to begin

using or distributing their tests prior to receiving an EUA from the agency, as long as they

submitted an EUA application within 15 business days of beginning clinical testing or distribution

of the test kit and notified the agency that the test was in use. Therefore, tests and test kits would

be in clinical use without having been granted an EUA (or 510(k) clearance, de novo

authorization, or premarket approval). In addition, the agency outlined a policy allowing states to

authorize laboratories within their state to carry out testing without FDA involvement; therefore,

these tests would also be in clinical use without authorization from the FDA (or 510(k) clearance,

de novo authorization, or premarket approval). Therefore, pursuant to the FDA’s updated March

16 guidance, some tests in clinical use would fall outside the definition at FFCRA Section

6001(a)(1) and may not be included in the above-referenced provisions’ requirements providing

payment for or requiring coverage of testing for the COVID-19 virus.

Provision

Section 3201 amended FFCRA Section 6001(a)(1) to include those IVDs (1) that have received

either 510(k) clearance, premarket approval, authorization pursuant to de novo classification, or

an EUA; (2) where the developer has requested, or intends to request, an EUA; (3) that are

developed in and authorized by a state that has notified the Secretary of its intention to review

tests intended to diagnose COVID–19; and (4) that are determined appropriate through guidance

by the Secretary.

Section 3202. Pricing of Diagnostic Testing

Background

42 CRS Report R46316, Health Care Provisions in the Families First Coronavirus Response Act, P.L. 116-127.

43 SARS-CoV-2 is the technical name of the virus that causes COVID-19 disease.

44 FDA, “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” March 16,




FFCRA Section 6001 created a requirement for most private health insurance plans to cover

specified COVID-19 testing and testing-related items and services.45 The coverage must be

provided without consumer cost-sharing, including deductibles, copayments, or coinsurance. This

coverage requirement applies to the specified items and services that are furnished during the

COVID-19 public health emergency described in FFCRA.46 The provision did not address the

reimbursement amount that a provider must receive from a health plan for furnishing COVID-19

testing.

In private health insurance, the amount paid for covered items and services is generally

contingent upon whether a consumer’s health plan has negotiated with a provider to enter into a

contract.47 The contract between the health plan and the provider generally specifies the total

amount that a provider may receive for furnishing particular items or services to that health plan’s

enrollees. A provider that enters into a contract with a health plan is considered to be part of the

health plan’s network, otherwise referred to as being in-network.

A provider that does not enter into a contract with a health plan is considered out-of-network and

as such there is no negotiated rate between the provider and the health plan. In situations

involving services provided by an out-of-network provider, the amount that a provider will

receive from a health plan depends on whether the health plan covers out-of-network services. In

situations where health plans do not cover out-of-network services, the health plan will not pay

any amount to a provider for services provided to an enrollee of the health plan. In situations

where plans do cover out-of-network services, as there is no negotiated rate between health plans

and out-of-network providers, health plans will use their own methodologies for calculating how

much they will pay out-of-network providers for services.

Provision

Section 3202 establishes a methodology for determining the amount that a health plan must

reimburse a provider for the COVID-19 testing, and testing-related items and services that are

required to be covered under FFCRA Section 6001(as amended).48 If a health plan had a

negotiated rate with a provider prior to the declaration of the COVID-19 public health emergency

declared under PHSA Section 319, then the health plan must apply that negotiated rate throughout

the period of the COVID-19 public health emergency.49 If a health plan did not have a negotiated

rate with a provider prior to the emergency declaration, then the health plan must either reimburse

the provider an amount that equals the cash price for the COVID-19 testing, as listed on the

provider’s public website, or the health plan and provider may negotiate a rate that is less than the

cash price.

During the period of the COVID-19 public health emergency, providers of COVID-19 diagnostic

testing must make public the cash price for the COVID-19 test on the provider’s public website.

45 For information on the types of plans subject to the coverage requirement and this payment requirement, see “See

Section 6001. Coverage of Testing for COVID-19” in CRS Report R46316, Health Care Provisions in the Families

First Coronavirus Response Act, P.L. 116-127. The definition of covered testing and related services in FFCRA Sec.

6001 was amended by the CARES Act. See “Section 3201. Coverage of Diagnostic Testing for COVID-19.”


47 For an overview of private health insurance billing, see the section “Private Health Insurance Billing Overview” in

CRS Report R46116, Surprise Billing in Private Health Insurance: Overview and Federal Policy Considerations.

48 See footnote 44.




The Secretary may impose a civil monetary penalty on a provider of COVID-19 diagnostic

testing that is not in compliance with the requirement to post the cash price for the COVID-19

testing and has not completed a corrective action plan to comply with the requirement. The

amount of the civil monetary penalty may not exceed $300 per day that the violation is ongoing.

Section 3203. Rapid Coverage of Preventive Services and Vaccines

for Coronavirus

Background

PHSA Section 2713 and accompanying regulations50 require most private health insurance plans

to cover, without cost-sharing,51 specified types of clinical preventive services. These include any

preventive service recommended with an A or B rating by the United States Preventive Services

Task Force (USPSTF),52 or any immunization with a recommendation by the Advisory

Committee on Immunization Practices (ACIP),53 adopted by CDC, for routine use for a given

individual. These coverage requirements apply no sooner than one year after a recommendation is

published.54

Requirements of Section 2713 apply to individual health insurance coverage and to small- and

large-group plans, whether fully insured or self-insured.55 The requirements do not apply to

grandfathered individual or group plans, or to short-term, limited duration insurance (STLDI).56

By regulation, plans are generally not required to cover preventive services furnished out-of-

network. Cost-sharing for office visits associated with a furnished preventive service may or may

not be allowed, as specified in regulation.57

Provision

Section 3203 requires specified plans—the same types of plans as those subject to PHSA Section

2713—to cover a COVID-19 vaccine and potentially other COVID-19 preventive services, as

recommended by ACIP or USPSTF, respectively.58 This coverage must be provided without cost-

sharing. Section 3203 also applies an expedited effective date for coverage of 15 business days

50 Section 2713 was added to the Public Health Service (PHSA) and incorporated into the Employee Retirement

Income Security Act (ERISA) and Internal Revenue Code (IRC) by the Patient Protection and Affordable Care Act

(ACA, P.L. 111-148, as amended). Regulations are at 29 C.F.R. 2590.715-2713, 26 C.F.R. 54.9815-2713, and 45

C.F.R. 147.130.

51 In general, private health insurance cost-sharing includes deductibles, coinsurance, and copayments. A deductible is

the amount an insured consumer pays for covered health care services before coverage begins (with exceptions, such as

the preventive services specified in this provision). Coinsurance is the share of costs, figured in percentage form, an

insured consumer pays for a health service. Co-payment is the fixed dollar amount an insured consumer pays for a

health service.

52 U.S. Preventive Services Task Force (USPSTF), https://uspreventiveservicestaskforce.org/uspstf/.

53 Advisory Committee on Immunization Practices (ACIP), https://www.cdc.gov/vaccines/acip/index.html.

54 Per 45 C.F.R. 147.130(b), such coverage is required “for plan years (in the individual market, policy years) that

begin on or after the date that is one year after the date the recommendation or guideline is issued.”

55 For more information about types of private health insurance plans, see CRS Report R45146, Federal Requirements

on Private Health Insurance Plans.

56 For more information about grandfathered plans and short-term, limited duration insurance (STLDI), see CRS Report

R46003, Applicability of Federal Requirements to Selected Health Coverage Arrangements.

57 In general, whether cost-sharing for office visits is allowed or prohibited depends on whether the preventive service

or item was the primary purpose of the visit, and whether the service or item was billed or tracked separately from the

office visit. See 45 C.F.R. 147.130(a)(2).

58 Cares Act Section 3203 refers to, but does not amend, PHSA Section 2713.



after an applicable ACIP or USPSTF recommendation is published. Otherwise, requirements of

Section 3203 mirror existing requirements under PHSA Section 2713.

Subpart B—Support for Health Care Providers

This subpart includes provisions that aim to extend the services available during the COVID-19

period and beyond, particularly for rural or otherwise underserved populations. The subpart

includes additional appropriations for health centers that provide care to populations that are

underserved or are located in underserved areas. Other provisions relate directly to health care

providers; for example, by conferring medical malpractice liability on health professionals who

choose to volunteer during the emergency period, by amending program rules for the NHSC

program to permit individuals to volunteer during the emergency period, and by clarifying aspects

of the USPHS Ready Reserve Corps program. The Ready Reserve Corps is composed of reserve

officers serving in other roles who would be subject to intermittent involuntary deployment (“call

up”) to bolster the available workforce for public health emergency missions. Finally, the subpart

reauthorizes and amends existing programs related to supporting rural health care providers and

encouraging the use of telehealth to expand access to care.

Section 3211. Supplemental Awards for Health Centers

Background

The federal health center program, authorized by PHSA Section 330 and administered by the

Health Resources and Services Administration (HRSA), provides grants to not-for-profit

organizations or state and local government entities to operate outpatient health centers.

Participation in the program requires grantees to provide care regardless of a patient’s ability to

pay, and grant funding is provided to support this care. These centers are also required to be

located in medically underserved areas (MUAs) or to provide care to a population that is

designated as underserved.59 Health centers are part of the health care safety net, and they have

been used as a way to fund safety net providers during prior disasters, when additional funds were

appropriated to make awards to existing grantees to respond to an emerging need.60 In FY2020,

health centers received a combination of discretionary and mandatory funding, which together

provided more than $5.6 billion to support the program.61 Health centers also received additional

funds in P.L. 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act,

2020, the first law to respond to COVID-19. That law provided the program with an additional

$100 million. These funds were awarded via formula to supplement existing health center

funding.62

59 For more information about these designations, see CRS Report R43937, Federal Health Centers: An Overview.

60 For example, health centers received additional funding to respond to the Zika virus outbreak. See Table 1 in CRS

Report R44460, Zika Response Funding: Request and Congressional Action.

61 For FY2019 and FY2020 funding amounts, see HHS, HRSA, “Justification of Estimates for Congressional

Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2021.pdf, pp.

17.

62 HHS, HRSA, “HHS Awards $100 Million to Health Centers for COVID-19 Response,” press release, March 24,

2020, https://www.hhs.gov/about/news/2020/03/24/hhs-awards-100-million-to-health-centers-for-covid-19-

response.html.



Provision

This section appropriates $1.32 billion in supplemental funding for health centers for FY2020 for

the detection of the COVID-19 virus, or prevention, diagnosis, and treatment of COVID-19

illnesses. The section also applies the limits on using these funds for abortion that were included

in Further Consolidated Appropriations Act, 2020 (P.L. 116-94), which provided FY2020

appropriations for HHS, among other agencies.63

Section 3212. Telehealth Network and Telehealth Resource Centers

Grant Programs

Background

PHSA Section 333(I) authorizes two telehealth programs that were authorized at “such sums as

may be necessary” through FY2006. Both programs have been funded since that time, despite the

lapsed authorization of appropriation. The programs are administered by HRSA. The first

program, authorized in PHSA Section 333I(d)(1), is the Telehealth Network Grant Program

(TNGP). This program aims to demonstrate how telehealth technologies can be used through

telehealth networks for medically underserved populations who live in rural areas, frontier

communities, and MUAs.64 Prior to passage of the CARES Act, only nonprofit entities were

eligible to apply for TNGP grants; however, prior law permitted both nonprofit and for-profit

organizations to participate in the grantees’ telehealth networks. The second program is the

Telehealth Resource Centers (TRC) Program. This program aims to coordinate telehealth

organizations that serve rural and underserved communities throughout the country, by providing

technical assistance to those organizations through national and regional TRCs.65 FY2020

appropriations report language provides $28.5 million to HRSA’s overarching Telehealth

Program, which includes both of these programs.66

Provision

This section amends PHSA Section 330I to make changes to both the TNGP and the TRC

programs. It makes the following changes:

(1) The Telehealth Network Grant Program (TNGP)

Grants. Section 3212 amends PHSA Section 330I by replacing the HRSA Administrator’s

Director’s authority to award grants to eligible grantees to demonstrate how telehealth

technologies can be used through telehealth networks, with the authority to award grants to

evidence-based projects that utilize telehealth technologies through telehealth networks. The

purpose of the TNGP now includes improving access to and quality of health care services for the

TNGP patient population. Grantees may no longer use TNGP funds to expand health care

provider training or for decision-making purposes.

63 Under federal law, federal funds are generally not available to pay for abortions, except in cases of rape, incest, or

endangerment of a mother’s life. This restriction is the result of statutory and legislative provisions like the Hyde

Amendment, which has been added to the annual appropriations measure for HHS since 1976.

64 42 U.S.C. §254c-14(d)(1).

65 42 U.S.C. §254c-14(d)(2); and CRS Report R46289, The National Consortium of Telehealth Resource Centers:

COVID-19 Assistance.

66 H.Rept. 116-62, p. 327. To learn about HRSA’s other telehealth programs, see HRSA, FY2021 Justification of

Estimates for Appropriations Committees, pp. 324-328, https://www.hrsa.gov/sites/default/files/hrsa/about/budget/

budget-justification-fy2021.pdf.



Grant period. Section 3212 allows the HRSA Administrator to extend the period of performance

for the TNGP from four years to five years. This section also makes administrative changes to the

statutory requirements on telehealth networks, including the nature of entities and composition of

telehealth networks. This section removes the statutory requirements that grantees of TNGP be

nonprofit entities and that telehealth networks be composed in a certain manner.

Applications. Grant applicants are now required to describe within their applications how the

applicants’ proposed TNGP projects will, among other things, improve access and quality of the

health care services that patients will receive. Prior to passage of the CARES Act, this provision

was optional.

Terms, conditions, maximum amount of assistance. Section 3212 removes the statutory

requirements that the Secretary has to establish the terms and conditions of the TNGP, as well as

the maximum amounts awarded to each TNGP recipient for each fiscal year. This section

removes the federal mandate that required the Secretary to publish, through HRSA, a notice of

application requirements for the TNGP program for each fiscal year.

Preferences. The Secretary is required to also give preference to eligible entities that develop

plans for or establish telehealth networks that provide mental health care services, public health

care services, long-term care, home care, preventive care, case management services, or prenatal

care for high-risk pregnancies. This section also expands preference to eligible entities that

propose projects that promote local and regional connectivity within areas, communities, and

populations served. The Secretary, however, may no longer give preference to applicants that

demonstrate integration of health care information into TNGP projects.

Distribution of funds. The HRSA Administrator no longer has to ensure that the total amount of

funds awarded in a given fiscal year is not less than the total amount awarded for projects in

FY2001. The HRSA Administrator must continue to ensure that no less than 50% of funds are

awarded to TNGP projects in rural areas.

Use of funds. Grantees no longer have the authority to use TNGP funds to purchase certain

equipment. Grantees are prohibited from purchasing computer hardware and software, audio and

video equipment, computer network equipment, interactive equipment, and data terminal

equipment. However, grantees may continue to purchase equipment that furthers the objectives of

the TNGP, such as to expand access to health care services.

Prohibited uses of funds. TNGP grantees are prohibited from using more than 20% of total grant

funds to purchase or lease equipment. Under prior law, grantees were allowed to use no more than

40% of total grant funds. Section 3212 also removes the examples of transmission equipment

from the list of items that TNGP funds cannot be used to purchase.

Report and regulations. The section requires the Secretary to submit a report, to specified

congressional committees, that describes the activities and outcomes of the TNGP, no later than

March 27, 2024, and every five years thereafter. The Secretary is no longer required to issue

regulations specifying the definition of frontier area.

(2) The Telehealth Resource Centers (TRC) Program

Grants and eligibility. Section 3212 amends PHSA Section 330I by replacing the HRSA

Administrator’s authority to award grants for projects to demonstrate how telehealth technologies

can be used in certain areas and communities, with the authority to award grants to support

initiatives that utilize telehealth technologies. The CARES Act removes the program’s authority

to establish new TRCs, which essentially makes the current TRCs permanent recipients of federal

funds under the program and does not allow for other entities to participate as TRCs. The section

also permits the HRSA Administrator to extend the period of performance for the TRC program



from four years to five years. Section 3212 removes the statutory requirement that grantees of the

TRC program be nonprofit entities.

Terms, conditions, maximum amount of assistance. Section 3212 removes the statutory

requirement that the Secretary has to establish the terms and conditions of the TRC program, as

well as the maximum amount awarded to each TRC program recipient for each fiscal year. This

section no longer requires the Secretary to publish, through HRSA, a notice of application

requirements for the TRC program for each fiscal year.

Preferences. The section requires the Secretary to also give preference to eligible entities with

successful records in delivering health care services to rural areas, MUAs, and medically

underserved populations.

Use of funds. The section specifies that grantees no longer have the authority to use TRC

program funds to foster certain telehealth activities. It also prohibits grantees from using funds to

foster the use of telehealth technologies to provide health care information. However, grantees

may continue to foster the use of telehealth technologies to educate health care providers and

consumers in an effective manner.

Report and regulations. The section requires the Secretary to submit a report, to specified

congressional committees, on the activities and outcomes of the TRC program, no later than

March 27, 2024, and every five years thereafter. (This report need not to be a separate report from

that required of the TNGP.) The Secretary is no longer required to issue regulations specifying the

definition of frontier area.

Authorization of appropriations. The section authorizes an appropriation of $29 million for

each of FY2021 through FY2025.

Section 3213. Rural Health Care Services Outreach, Rural Health Network

Development, and Small Health Care Provider Quality Improvement Grant

Programs

Background

PHSA Section 330A authorizes three grant programs supporting rural health care providers: the

rural health care services outreach grants, the rural health network development grants, and the

small health care provider quality improvement grants. These programs are administered by

HRSA’s Federal Office of Rural Health Policy (FORHP).67 In each case, grants are available to

nonprofit or governmental health entities for a period of three years. The Rural Health Network

Development program also permits additional one-year planning grants. Funds for the program

had been authorized at $45 million annually through FY2012, and required a one-time report to

Congress that was required at the end of FY2005. Despite the lapsed authorizations of

appropriations, these programs have continued to be funded in recent years. Most recently, the

programs received an appropriation of $79.5 million in FY2020.68

Provision

This section makes a number of technical corrections to PHSA Section 330A. It also replaces

language related to essential health services to make reference to basic health services, extends

the duration of Rural Health Care Service Outreach grants and Rural Health Network

67 HHS, HRSA, “Rural Community Programs,” https://www.hrsa.gov/rural-health/community/index.html.

68 HHS, HRSA “Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/

default/files/hrsa/about/budget/budget-justification-fy2021.pdf, p. 20.



Development grants from three to five years, and expands eligibility for the programs to any rural

health entity (prior eligibility was limited to rural public or nonprofit health entities). The section

also eliminates the one-year planning grants from the Rural Health Network Development

program and extends the grant period of the Small Health Care Quality Improvement grants from

three to five years. Finally, the section requires a report, to be delivered to specified congressional

committees, on these grant programs, not later than four years after enactment and every five

years thereafter, and authorizes an appropriation of $79.5 million for each of FY2020 through

FY2025. No additional funding for FY2020 is appropriated in this provision.

Section 3214. United States Public Health Service Modernization

Background

The USPHS Commissioned Corps is a branch of the U.S. uniformed services, but it is not one of

the armed services.69 The Corps is based in HHS under the authority of the U.S. Surgeon General

(SG). USPHS-commissioned officers are physicians, nurses, pharmacists, engineers, and other

public health professionals who serve in federal agencies, or as detailees to state or international

agencies, to support a variety of public health activities. ACA (the Patient Protection and

Affordable Care Act, P.L. 111-148, as amended), Section 5210, authorized a USPHS Ready

Reserve Corps—reserve officers serving in other roles who would be subject to intermittent

involuntary deployment (“call up”) to bolster the available workforce public health emergency

missions.70 HHS had not received an appropriation for this purpose and had not established a

Ready Reserve Corps. It has been reported that the ACA authority did not fully authorize this

action, and legislation (S. 2629, the United States Public Health Service Modernization Act of

2019) was introduced to address this.71

Provision

Section 3214 enacts the language of S. 2629, making several technical and substantive

amendments to PHSA Title II to clarify provisions regarding deployment readiness, retirement,

compensation, and other matters as they would affect the Ready Reserve Corps.72

Section 3215. Limitation on Liability for Volunteer Health Care Professionals

During COVID-19 Emergency Response

Background

In 1997, Congress enacted the Volunteer Protection Act of 1997 (VPA; P.L. 105-19).73 This act

provides that a volunteer at a nonprofit organization or governmental entity is not liable for the

69 10 U.S.C. §101. The Commissioned Corps of the U.S. Public Health Service is authorized in PHSA Secs. 201-224

(42 U.S.C. §§202-233). For more information see HHS, USPHS Commissioned Corps, http://www.usphs.gov/

default.aspx.

70 See “Sec. 5210. USPHS Ready Reserve Corps” in CRS Report R41278, Public Health, Workforce, Quality, and

Related Provisions in ACA: Summary and Timeline.

71 Scott Maucione, “Public Health Service Gets Congressional Attention for Ready Reserve Corps,” Federal News

Network, November 4, 2019, https://federalnewsnetwork.com/workforce/2019/11/public-health-service-gets-

congressional-attention-for-ready-reserve-corps/.

72 In addition, the CARES Act provides about $27 billion in emergency supplemental appropriations to the HHS

Secretary, through the Public Health and Social Services Emergency Fund, for numerous stated purposes, including

“enhancements to the U.S. Commissioned Corps.”

73 Codified at 42 U.S.C. §§14501-14505.



harm he or she causes by an act (or an act of omission) on behalf of the organization, provided the

following: (1) the volunteer was, among other things, properly licensed, certified, or authorized

for the activities in a state, if applicable; (2) the volunteer was acting within the scope of his or

her responsibilities in the organization at the time of the act (or act of omission); and (3) the harm

was not caused by “willful or criminal misconduct, gross negligence, reckless misconduct, or a

conscious, flagrant indifference to the rights or safety of the individual harmed by the

volunteer.”74 The law does not convey liability protections in certain instances (e.g., when

misconduct is a criminal act or when the defendant acted under the influence of drugs or

alcohol),75 and the law specifies how it interacts with relevant state law.76 This law was not

specific to health professionals in a volunteer capacity but, rather, covered all types of volunteers.

Provision

This section limits the medical malpractice liability of health professionals who volunteer during

the COVID-19 emergency. Specifically, it limits the liability under federal and state law for any

harm caused by an act or omission while providing health services during the emergency,

provided that the health services are within the scope of the health professional’s license

registration, or certification, and that the health professional acted in good faith. The section

specifies that health professionals do not have liability protections in situations where harm was

caused by “willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious

flagrant indifference to the rights or safety of the individual harmed by the health care

professional,” or when services were provided by a health professional who was under the

influence of drugs or alcohol. The section specifies that it preempts state or local laws that are

inconsistent with this section, unless those laws provide great liability protections, and specifies

that the liability protections are in addition to those provided under the VPA. Finally, the section

defines relevant terms and specifies that this provision is effective at enactment and will remain

in effect for the length of the public health emergency declared by the Secretary under PHSA

Section 319, declared by the Secretary on January 30, 2020.

Section 3216. Flexibility for Members of National Health Service Corps During

Emergency Period

Background

The federal government supports a number of health workforce programs administered by HRSA.

Among the largest of these programs is the NHSC, which provides scholarships and loan

repayment to health care providers in exchange for a two-year or more service commitment in a

health professional shortage area (HPSA).77 The program is authorized in PHSA Sections 332-

338I. PHSA Section 333 specifies the types of health care facilities and the conditions they must

meet to receive NHSC personnel. Generally, these are outpatient health facilities in HPSAs.78

74 Id. §14503(a).

75 Id. §14503(g).

76 Id. §14502(a) (preempting state laws to the extent of inconsistency with the Volunteer Protection Act (VPA), but not

preempting state laws that provide greater liability protections for volunteers).

77 CRS Report R44970, The National Health Service Corps. For more information about health professional shortage

areas (HPSAs), see CRS Infographic IG10015, Health Professional Shortage Areas (HPSAs).

78 Certain inpatient facilities are permitted, such as critical access hospitals and Indian Health Service (IHS) facilities.



Provision

This section specifies that for the duration of the public health emergency declared under PHSA

Section 319 for the COVID-19 response, the Secretary may waive the requirements in PHSA

Section 333 in order to assign NHSC members to voluntarily provide health services to respond

to the emergency. The provision allows NHSC members to volunteer services for the number of

hours that the Secretary determines appropriate. The provision further specifies that NHSC

members must be assigned voluntarily, that the assignment site must be in reasonable proximity

to the NHSC corps member’s original practice site, and that these hours are to count toward

fulfilling their NHSC service commitment.

Subpart C—Miscellaneous Provisions

Section 3221. Confidentiality and Disclosure of Records Relating to Substance

Use Disorder

Background

Generally, the privacy of health information is governed by the HIPAA (Health Insurance

Portability and Accountability Act of 1996, P.L. 104-191, as amended) Privacy Rule, which

establishes requirements for covered entities’ (health care plans, providers, and clearinghouses)

and their business associates’ use and disclosure of protected health information (PHI). All health

information is generally treated similarly under the HIPAA Privacy Rule, with certain exceptions

in place relating to the use and disclosure of psychotherapy notes. In contrast, stricter federal

privacy requirements at PHSA Section 543—requirements promulgated in and commonly known

as the “Part 2” rule—apply to individually identifiable patient information received or acquired

by federally assisted substance use disorder programs.79 Specifically, the Part 2 rule governs any

information that would identify a patient as having or having had a substance use disorder, and

that is obtained or maintained by a federally assisted substance use disorder program for the

purpose of treating a substance use disorder, making a diagnosis for that treatment, or making a

referral for that treatment.80 Part 2 requirements apply to an individual or entity (other than a

general medical facility) that is federally assisted and provides—and holds itself out as

providing—diagnosis, treatment, or referral for treatment of substance use disorders.81 “Federally

assisted programs” include programs that are carried out in whole or in part by the federal

government or supported by federal funds.

The Part 2 rule strictly regulates the disclosure and redisclosure of patient identifying information

held by Part 2 programs. The rule allows disclosure of this information only either (1) with

written patient consent or (2) pursuant to exceptions in statute or regulation (e.g., for a medical

emergency, for research). A general authorization for the release of medical information does not

satisfy the rule’s requirement for written consent, although a general designation in consent is

allowed in cases where a class of participants may receive and redisclose amongst themselves

Part 2 information if there exists a treatment relationship.82 Further, the rule strictly prohibits the

subsequent redisclosure of information received from a Part 2 program without consent from the

patient, and a notification clearly prohibiting this redisclosure by the receiving entity travels with

79 42 U.S.C. §290dd-2; 42 C.F.R. Part 2.

80 42 C.F.R. §2.12(a).

81 42 C.F.R. §2.12(b).

82 42 C.F.R. §2.31(a)(4)(iii)(3).



any disclosed Part 2 information. Under PHSA Section 543(f), any person who violates any

provision of the section or any regulation issued pursuant to the section shall be fined in

accordance with Title 18 of the U.S. Code.83

Provision

Section 3221 amends PHSA Section 543 to allow for, pursuant to written consent, the use or

disclosure of covered records by a covered entity, business associate, or a Part 2 program for

purposes of treatment, payment, and health care operations as permitted by the HIPAA Privacy

Rule. In addition, the section allows information disclosed pursuant to this exception to be

subsequently redisclosed in accordance with the HIPAA Privacy Rule. It further allows the

disclosure of deidentified records to public health authorities, without written consent, if the

information meets the deidentification standards in the HIPAA Privacy Rule.84

Section 3221 applies the penalties under SSA Sections 1176 and 1177 for violations of PHSA

Section 543, as specified. It also prohibits discrimination against an individual on the basis of

information received pursuant to an inadvertent or intentional disclosure of covered records, or

information contained in covered records, in multiple instances (e.g., employment, access to

courts). The section applies the HIPAA breach notification requirements to a program or activity

under PHSA Section 543 in case of a breach of records.85 Section 3221 requires the Secretary to

revise regulations as necessary such that changes in the section apply with respect to uses and

disclosures of covered records occurring on or after the date that is 12 months after enactment. It

also requires the Secretary, not later than one year after enactment and in consultation with

appropriate legal, clinical, privacy, and civil rights experts, to update the notice of privacy

practices requirement in the HIPAA Privacy Rule86 to require covered entities and entities

creating or maintaining covered records to provide notice, in plain language, of privacy practices

regarding those records. The section also establishes that nothing in the act shall be construed to

limit (1) the right of an individual to request a restriction on the use or disclosure of a record

under PHSA Section 543 for purposes of treatment, payment, or health care operations, and (2)

the choice of a covered entity to obtain consent to use or disclose a covered record for purposes of

treatment, health care operations, or payment.

Section 3222. Nutrition Services

Background

The OAA (Older Americans Act, P.L. 89-73, as amended; 42 U.S.C. §§3001 et seq.) Nutrition

Services Program provides grants to states and U.S. territories under Title III of the act to support

congregate nutrition services (i.e., meals served at group sites such as senior centers, community

centers, schools, churches, and senior housing complexes) and home-delivered nutrition programs

for individuals aged 60 and older.87 The Nutrition Services Program is designed to address

problems of food insecurity, promote socialization, and promote the health and well-being of

older persons through nutrition and nutrition-related services. The program is administered by the

Administration for Community Living (ACL) under HHS. States and territories receive separate

funding allotments for each program based on a statutory funding formula. Under OAA, states

83 42 U.S.C. §290dd-2(f).

84 45 C.F.R. §164.514(b).

85 45 C.F.R. 164 Part D.

86 45 C.F.R. §164.520.

87 For more information, see CRS In Focus IF10633, Older Americans Act: Nutrition Services Program.



and U.S. territories have authority to transfer up to 40% of their allotments between congregate

and home-delivered nutrition services and can request waivers to transfer up to 10% of additional

funding between these programs. In addition, OAA provides states authority to transfer up to 30%

of program funding from the Supportive Services Program to the Nutrition Services Program.88

Nutrition services providers are required to offer at least one meal per day, five or more days per

week (except in rural areas, where the provision of meals may be less frequent).89 The meals must

comply with the Dietary Guidelines for Americans published by the Secretary of HHS and the

Secretary of Agriculture. Providers must serve meals that meet specified minimum amounts for

the daily recommended dietary reference intakes (DRIs) established by the Food and Nutrition

Board of the National Academies of Sciences, Engineering, and Medicine based on the number of

meals served by the project each day.90 With respect to home-delivered nutrition programs,

individuals aged 60 or older and their spouses (regardless of age) may participate in the home-

delivered nutrition program. Persons aged 60 or over who are frail, homebound by reason of

illness or disability, or otherwise isolated, are also prioritized for OAA Title III services.91

Services may be available to individuals under age 60 with disabilities if they reside at home with

the older individual.92 Service eligibility is determined by the states and local Area Agencies on

Aging (AAA); however, according to the ACL, entities may waive any eligibility requirements

they have established for home-delivered meals in response to the COVID-19 pandemic.93

Provision

During any portion of the COVID-19 public health emergency declared under PHSA Section 319,

the section sets forth additional transfer authority between OAA nutrition programs, clarifies

participant requirements for home-delivered meals, and authorizes the Assistant Secretary for

Aging to waive certain dietary requirements for nutrition services. Specifically, the HHS

Secretary is required to allow a state agency or an AAA to transfer up to 100% of the funds

appropriated and received for congregate and home-delivered nutrition between these two

programs, for such use as the state or area considers appropriate to meet service needs without

prior approval. For purposes of state agencies’ determining the delivery of nutrition services, the

provision requires the same meaning to be given to individuals who are unable to obtain nutrition

because they are practicing social distancing due to the emergency as is given to an individual

who is homebound because of illness. And, to facilitate implementation of nutrition services

programs, the Assistant Secretary is authorized to waive compliance with the Dietary Guidelines

for Americans and the specified minimum amounts for the daily recommended DRI requirements.

88 On March 13, 2020, the President declared that the ongoing COVID-19 pandemic is of sufficient severity and

magnitude to warrant an emergency determination under §501(b) of the Robert T. Stafford Disaster Relief and

Emergency Assistance Act (“Stafford Act”; 42 U.S.C. 5121-5207). The emergency exists nationwide. Under the

declaration, states, U.S. territories, and tribes may consider requests for a declaration of a “major disaster” under

Section 401(a) of the Stafford Act. A major disaster declaration under the Stafford Act triggers disaster relief authority

in the Older Americans Act (OAA) should a state (including a U.S. territory) or tribe (OAA Title VI grantee) request

and receive such declaration. Specifically, OAA Section 310 provides authority for states to use any portion of funding

made available under any and all sections of the act for disaster relief provided to older individuals. For further

information, see Agency for Community Living (ACL) guidance issued March 16, 2020, at https://acl.gov/sites/default/

files/common/OAADisasterRelief_2020-03-16.pdf.

89 42 U.S.C. §3030e-f.

90 42 U.S.C. §3030g-21.

91 45 C.F.R. §1321.69.

92 42 U.S.C. §3030g-21.

93 ACL, “Information for the Aging and Disability Networks, Grant and Program Guidance, Older Americans Act

Programs,” https://acl.gov/COVID-19.



The provision defines the terms ‘‘Assistant Secretary,’’ ‘‘Secretary,’’ ‘‘State agency,’’ and ‘‘area

agency on aging’’ to have the same meanings as under OAA Section 102.

Section 3223. Continuity of Service and Opportunities for Participants in

Community Service Activities Under Title V of the Older Americans Act

Background

OAA Title V establishes the Community Service Employment for Older Americans program

(CSEOA), sometimes referred to as the Senior Community Service Employment Program

(SCSEP). CSEOA promotes part-time employment opportunities in community service activities

for unemployed low-income persons aged 55 and older and who have poor employment

prospects.94 The Title V program is administered by the Department of Labor’s (DOL’s)

Employment and Training Administration. DOL allocates Title V funds for grants based on a

statutory funding formula to state agencies in all 50 states, the District of Columbia, Puerto Rico,

and the U.S. territories, and to national organizations. Program participants work part-time in

community service jobs, including employment at schools, libraries, social service organizations,

and senior-serving organizations. Program participants earn the higher of minimum wage or the

typical wage for the job in which they are employed. An individual may typically participate in

the program for a cumulative total of no more than 48 months.95

Provision

Due to the effects of the COVID-19 public health emergency declared under PHSA Section 319,

this section specifies additional flexibility for the Secretary of Labor with respect to

administration and implementation of the CSEOA program. Specifically, it authorizes the

Secretary to allow individuals participating in OAA Title V projects as of March 1, 2020, to

extend their participation for a period that exceeds 48 months in the aggregate, as determined by

the Secretary. It authorizes the Secretary to increase the average participation cap for grantees of

27 months for eligible individuals to a cap the Secretary determines is appropriate. And it

authorizes the Secretary to increase the amount available to pay the authorized administrative

costs for a project, which is currently 13.5% of the grant amount, to not exceed 20% of the grant

amount, if the Secretary determines that such increase is necessary to adequately respond to

additional administrative needs.

Section 3224. Guidance on Protected Health Information

Background

94 For more information, see CRS Report R45626, Older Americans Act: Senior Community Service Employment

Program.

95 42 U.S.C. §3056.



The HIPAA Privacy Rule governs covered entities’ (health care plans, providers, and

clearinghouses)96 and their business associates’ use and disclosure of PHI.97 In addition, it

establishes strong individual rights of access to an individual’s own PHI. PHI is defined as

individually identifiable health information created or received by a covered entity that is

transmitted by electronic media, maintained in electronic media, or transmitted or maintained in

any other form or medium.98 The rule sets forth multiple situations in which covered entities may

permissibly use or disclose PHI without written authorization, while generally all other uses and

disclosures of PHI (i.e., those that are not expressly permitted under the rule) require an

individual’s prior written authorization. Broadly, covered entities may share PHI between and

among themselves for the purposes of treatment, payment, or health care operations, with few

restrictions and, specifically, without the individual’s authorization.99 The Privacy Rule also

recognizes that PHI may be useful or necessary in circumstances besides health care treatment

and payment for a given individual or general health care operations, or entirely unrelated to

health care or the health care system. For this reason, the rule lists a number of “national priority

purposes” for which covered entities may disclose PHI without an individual’s authorization or

opportunity to agree or object.100 Examples of these include disclosures for public health

activities, health oversight, and pursuant to a requirement in law (e.g., state law).

In response to the COVID-19 pandemic, the Office of Civil Rights (OCR)/HHS has issued

guidance relating to the disclosure of PHI to first responders and law enforcement, as well as on

telemedicine and the HIPAA Privacy Rule. OCR has also released several notifications of

exercise of enforcement discretion during the COVID-19 public health emergency, specifically

with respect to use and disclosure of PHI by business associates (BAs); the operation of

Community-Based Testing Sites during the COVID-19 public health emergency; and the

provision of care using telehealth.101 In addition, under authorities in SSA Section 1135 and the

Project Bioshield Act (P.L. 108-276), the Secretary has the authority to waive sanctions and

penalties for certain HIPAA Privacy Rule violations during certain emergency periods. These

have been waived. The specific HIPAA Privacy Rule requirements for which penalties may be

waived are as follows: (1) the requirement to distribute a notice of privacy practices (45 C.F.R.

§164.520); (2) the patient’s right to request certain privacy restrictions (45 C.F.R. §164.522(a));

(3) the patient’s right to request confidential communications (45 C.F.R. §164.522(b)); (4) the

requirement to honor a request to opt out of a facility directory (45 C.F.R. §164.510(a)); and (5)

the requirement to obtain agreement to share information with family and friends involved in a

patient’s care (45 C.F.R. §164.510(b)). These waivers apply only (1) in the emergency area

identified in the public health emergency declaration and for the duration of the emergency, (2) to

96 A health care clearinghouse is defined in the Rule as: “a public or private entity, including a billing service, repricing

company, community health management information system or community health information system, and ‘value-

added’ networks and switches, that does either of the following functions: (1) Processes or facilitates the processing of

health information received from another entity in a nonstandard format or containing nonstandard data content into

standard data elements or a standard transaction; [or] (2) Receives a standard transaction from another entity and

processes or facilitates the processing of health information into nonstandard format or nonstandard data content for the

receiving entity.” [45 C.F.R. §160.103]

97 45 C.F.R. 164 Subparts A and E.

98 45 C.F.R. §160.103.

99 45 C.F.R. §164.506.

100 45 C.F.R. §164.512.

101 HHS, “HIPAA, Civil Rights, and COVID-19,” https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-

covid19/index.html.



those hospitals that have a disaster plan; and (3) for the first 72 hours after the hospital’s plan has

been initiated.102

Provision

Section 3224 requires the Secretary, not later than 180 days after enactment, to issue guidance on

the sharing of patients’ PHI (as defined at 45 C.F.R. §106.103) during emergency declarations and

determinations, with respect to COVID-19, pursuant to PHSA Section 319, Section 501(b) of the

Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), and the National

Emergencies Act. The section requires the guidance to address compliance with the HIPAA

Privacy Rule and applicable policies, including any policies that may come into effect during

these emergencies.

Section 3225. Reauthorization of Healthy Start Program

Background

The Healthy Start Program (Healthy Start), which is authorized in PHSA Section 330H and

administered by HRSA, is a competitive grant program.103 The program enables eligible public or

private entities, community-based organizations, faith-based organizations, and Indian or tribal

organizations to propose and administer innovative, community-based ways to decrease U.S.

infant mortality rates (IMRs), improve perinatal and maternal health outcomes, and reduce ethnic

and racial health disparities in perinatal health. (Infant mortality refers to the death of an infant

before his or her first birthday. An infant mortality rate refers to the comparison of the number of

infant deaths against 1,000 live births in a given year.)104 Healthy Start participants consist of

women, men, infants, children, and involved parties such as family members. The program

requires participants to reside in communities with IMRs that are at least 1.5 times greater than

the U.S. IMR and/or have high rates of adverse perinatal outcomes such as preterm births and

maternal deaths.105 The program’s authorization of appropriations, which expired in 2013, was

“the amount authorized for the preceding fiscal year increased by the percentage increase in the

Consumer Price Index (CPI) for all urban consumers for such year.”106

Provision

Purpose and considerations in making grants. Section 3225 amends PHSA Section 330H by

expanding the Healthy Start project areas to those with increasing IMRs that are above the U.S.

IMR. Section 3225 removes the mandate that required applicants to include consumers of project

services as participants in community-based consortiums. The Secretary instead must require

applicants to include state substance abuse agencies, participants, and former participants of

project areas as participants in community-based consortiums.

The Secretary, when considering grant awards, is required to consider factors that contribute to

infant mortality, including poor birth outcomes (e.g., low birthweight and preterm birth) and

102 HHS, “March 2020: COVID-19 and HIPAA Bulletin: Limited Waiver of HIPAA Sanctions and Penalties During a

Nationwide Public Health Emergency,” https://www.hhs.gov/sites/default/files/hipaa-and-covid-19-limited-hipaa-

waiver-bulletin-508.pdf.

103 42 U.S.C. §254c-8; and HRSA, Healthy Start, https://mchb.hrsa.gov/maternal-child-health-initiatives/healthy-start.

104 CDC, Reproductive Health: Infant Mortality, https://www.cdc.gov/reproductivehealth/maternalinfanthealth/

infantmortality.htm.

105 HRSA, Healthy Start Initiative: Eliminating Disparities in Perinatal Health, Notice of Funding Opportunity,

October 16, 2018, p. 1, https://www.hrsa.gov/grants/find-funding/hrsa-19-049.

106 42 U.S.C. §254c-8.



social determinants of health. In addition, the Secretary must consider factors such as applicants’

collaboration with the local community in developing Healthy Start projects and applicants’ use

and collection of data demonstrating the program’s effectiveness in decreasing IMRs and

improving perinatal outcomes.

Coordination. Section 3225 makes conforming changes and moves the current language in

subsection (c) to a new paragraph (1) and adds a new paragraph (2), under subsection (c). The

new paragraph (2) requires the Secretary to ensure the Healthy Start program coordinates with

similar programs and activities administered by HHS that aim to reduce IMRs and improve infant

and perinatal health outcomes.

Funding. The section authorizes an appropriation of $125.5 million for each of FY2021-FY2025,

eliminates the CPI requirement, and authorizes the Secretary to reserve 1% of appropriated funds

to evaluate Healthy Start projects. Section 3225 expands the Secretary’s use of the reserved funds

to evaluate information related to, among other things, progress made toward meeting program

metrics or health outcomes on reducing IMRs, improving perinatal outcomes, and diminishing

health disparities.

GAO report. Section 3225 makes conforming changes and adds a new subsection (f). The new

subsection requires the Government Accountability Office (GAO) to conduct an independent

evaluation of Healthy Start and to submit a report to appropriate congressional committees, no

later than March 27, 2024. The section specifies that the evaluation must include a determination

of whether Healthy Start projects have been effective in reducing the health disparity in health

care outcomes between the general population group and racial and minority population groups,

where applicable and appropriate. The report must also contain a review, an assessment, and

recommendations on, among other topics, HRSA’s allocation of funding to urban and rural areas

and progress towards meeting the evaluation criteria for programs that increase and decrease

IMRs, improve and adversely affect perinatal outcomes, and affect disparities in infant mortality

and perinatal health outcomes.

Section 3226. Importance of the Blood Supply

Background

The nation’s blood supply is largely managed by a network of independent blood centers and the

American Red Cross, with some oversight from HHS.107 These organizations collect blood

product donations (e.g., whole blood, platelets) from individuals through scheduled appointments,

walk-in appointments, and blood drives.

The COVID-19 pandemic poses significant challenges for the United States’ blood supply.

Mitigation strategies to prevent the spread of COVID-19, such as closures of schools and

workplaces, have led to blood drive cancellations, resulting in a critical blood supply shortage. In

addition, individuals are reluctant to schedule blood donations while advised to social distance

from others.108

Provision

This section requires the Secretary to carry out a national campaign to improve awareness of, and

support outreach to the public and health care providers about, the importance and safety of blood

107 For more information on independent blood centers, see https://americasblood.org/about/. For more information on

the American Red Cross, see https://www.redcross.org/give-blood.html.

108 For more information, see CRS Insight IN11238, Coronavirus Disease 2019 (COVID-19) Poses Challenges for the

U.S. Blood Supply.



donation and the need for donations for the blood supply. The section requires the Secretary to

consult with heads of relevant federal agencies (including FDA, CDC, and National Institutes of

Health [NIH]), accrediting bodies, and representative organizations to carry out the campaign. In

addition, the Secretary is authorized to enter into contracts with public or private nonprofit

entities to carry out the campaign.

The section requires the Secretary to submit a report to specified congressional committees, not

later than two years from enactment that (1) describes the activities carried out, (2) describes

trends in blood supply donations, and (3) evaluates the impact of the public awareness campaign.

Part III—Innovation

This part adds two new authorities to the broad body of law that provides incentives for medical

product research and development.109

Section 3301. Removing the Cap on OTA During Public Health Emergencies

Background

The Biomedical Advanced Research and Development Authority (BARDA) supports the clinical

research and development, regulatory approval, and procurement of new MCMs (e.g., vaccines,

treatments, and diagnostics) planned for use in public health emergencies. In addition to grants,

contracts, and cooperative agreements, the PHSA permits BARDA to enter into “other

transactions,” which are exempt from many statutory provisions and procurement regulations. In

February 2020, BARDA announced it was using its other transaction authority (OTA) to expand

existing relationships with private partners to speed the development of COVID-19

countermeasures.110 In general, such transactions above $100 million require a written

determination “by the Assistant Secretary for Financial Resources, that the use of such authority

is essential to promoting the success of the project.”111

Provision

Section 3301 amends PHSA Section 319L in a number of ways that appear to be somewhat

ambiguous, but the intent seems to be to waive the requirement for a written determination for

transactions above $100 million during a public health emergency declared under PHSA Section

319. Transactions made under this provision would not be terminated solely due to the expiration

of the public health emergency. The Secretary is required to report the use of this provision to

specified congressional committees after the public health emergency ends.

Section 3302. Priority Zoonotic Animal Drugs

Background

109 See, for example, CRS In Focus IF11379, Medical Product Innovation and Regulation: Benefits and Risks; and

HHS Biomedical Advanced Research and Development Authority (BARDA), “BARDA’s Rapidly-Expanding COVID-

19 Medical Countermeasure Portfolio,” https://www.medicalcountermeasures.gov/app/barda/coronavirus/

COVID19.aspx.

110 HHS, Press Release, “HHS, Janssen Collaborate to Develop Coronavirus Therapeutics,” February 18, 2020; and

HHS, Press Release, “HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment,” February 4, 2020.

111 42 U.S.C. 247d-7e(c)(5)(ii)(II).



A zoonotic disease is an infectious disease that is transmissible between humans and nonhuman

animals. Many emerging infections that have caused significant outbreaks among humans, are

believed to have arisen from animal-to-human transmission. Drugs to treat animals are evaluated

for approval by FDA. An animal origin for the COVID-19 virus is considered likely but

unproven.112

Provision

Section 3302 adds a new Section 512A to the FFDCA regarding Priority Zoonotic Animal Drugs.

It requires the Secretary, upon an applying drug sponsor’s request, to expedite the development

and review of a new animal drug “if preliminary clinical evidence indicates that the new animal

drug, alone or in combination with 1 or more other animal drugs, has the potential to prevent or

treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to

cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.”

The request may be made upon, or any time after, the opening of an investigational new animal

drug file or filing of an application for approval, and the Secretary shall act on such request

within 60 days. Actions that may be used to expedite review include expanded consultations and

guidance regarding novel designs or drug development tools to make clinical trials more efficient.

Part IV—Health Care Workforce

PHSA Title VII authorizes a number of programs to support the health workforce. These include

scholarships, loans, and academic programs that seek to diversify the workforce, train primary

care providers, and increase the number of geriatric health care providers, among other things.

PHSA Title VIII authorizes similar programs to support the nursing workforce.

Many of Title VII and Title VIII programs were most recently reauthorized in Title V of the ACA,

which made program changes, added new programs, and generally provided authorizations of

appropriations through either FY2013 or FY2014. Although authorizations of appropriations for

most Title VII and Title VIII have lapsed, a number of these programs have continued to receive

appropriations through HRSA’s Bureau of the Health Care Workforce.113 These programs have

also been considered for reauthorization in the 116th Congress, where bills would typically

provide a five-year authorization of appropriations at the amounts provided in the most recent

fiscal year. For example, S. 2997, Title VII Health Care Workforce Reauthorization Act of

2019,114 would have reauthorized a number of Title VII programs for five years, and would have

authorized funding at FY2019 funding levels. Much of S. 2997 was included in Sections 3401-

3403 of the CARES Act, generally with funding amounts reflective of FY2020 appropriations and

with a five-year authorization that begins in FY2021. Similarly, S. 1399, Title VIII Nursing

Workforce Reauthorization Act of 2019,115 would have reauthorized a number of Title VIII

112 See “Are animals responsible for COVID-19 in people?” in World Organization for Animal Health (known by its

French acronym, OIE), “Questions and Answers on the 2019 Coronavirus Disease (COVID-19),” April 20, 2020,

https://www.oie.int/scientific-expertise/specific-information-and-recommendations/questions-and-answers-on-

2019novel-coronavirus/. OIE is the intergovernmental organization responsible for analyzing and disseminating

information related to animal disease control. See also CRS In Focus IF11494, Wildlife Trade, COVID-19, and Other

Zoonotic Diseases.

113 For a description of the most recent reauthorization, see CRS Report R41278, Public Health, Workforce, Quality,

and Related Provisions in ACA: Summary and Timeline. For FY2019 and FY2020 funding amounts, see HHS, HRSA,

“Justification of Estimates for Congressional Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/

about/budget/budget-justification-fy2021.pdf, pp. 17-18.

114 See version of S. 2997, as reported to the Senate on December 17, 2019.

115 See version of S. 1399, as reported to the Senate on November 5, 2019.



programs for five years, and would have authorized funding at FY2019 funding levels. Much of

what was included in S. 1399 was enacted in Section 3404 of the CARES Act, with funding

amounts reflective of FY2020 appropriations and with a five-year authorization that begins in

FY2021.

Section 3401. Reauthorization of Health Professions Workforce Programs

Background

PHSA Title VII authorizes a number of programs to support the health workforce. Though

authorizations of appropriations for most Title VII programs have lapsed, several programs have

received appropriations in recent years.116 The relevant Title VII programs (with their FY2020

appropriation level, if appropriate) are summarized below. The summary also notes other relevant

PHSA Title VII advisory groups amended by this section.

Centers of Excellence (Section 736) supports centers that seek to recruit, retain, and train

underrepresented minorities in the health professions. The program received an appropriation of

$23.711 million in FY2020.

Health Professions Training for Diversity (Section 740) authorizes appropriations for a number

of diversity-related training programs. Subsection (a) authorizes appropriations for scholarships

for disadvantaged students (PHSA §737), which received an appropriation of $51.47 million in

FY2020; subsection (b) authorizes appropriations for loan repayment and fellowships for

minority health professional faculty (PHSA §738), which received an appropriation of $1.19

million in FY2020; subsection (c) authorizes appropriations for the Health Careers Opportunity

Program (PHSA §739), which provides grants for programs that provide health career training to

individuals from disadvantaged backgrounds. This program received an appropriation of $15

million in FY2020, and subsection (d) required a report on diversity in the health professions that

was due not later than six months after enactment.117

Primary Care Training and Enhancement (Section 747) authorizes grant programs to support

primary care medicine and physician assistant training. The program received an appropriation of

$48.925 million in FY2020.

Training in General, Pediatric, and Public Health Dentistry (PHSA Section 748) authorizes

grants to support dentists and dental hygienist training. The program received an appropriation of

$28 million in FY2020.118

Advisory Committee on Training in Primary Care Medicine and Dentistry (Section 749) authorizes the advisory committee that provides oversight over PHSA Section 747 and Section

748 programs. Authorizations of appropriations for those programs are contained in their

respective authorizing provisions. Section 749 was renumbered in the ACA, but its language was

not amended at that time.


Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2021.pdf, pp.

17-18.

117 This section was not amended in the ACA as such, the section was enacted in November 1998, so the original report

was due in 1999 (42 U.S.C. §293(d)(d)).

118Amounts obtained from the HRSA Operating plan and have been rounded to the nearest million; see HHS, HRSA,

“FY2020 Operating Plan,” https://www.hrsa.gov/about/budget/operating-plan.html.



Area Health Education Centers (Section 751) authorizes grants for centers at medical or

nursing schools that provide training for students from underserved backgrounds or in

underserved (often rural) areas. This program received $41.25 million in FY2020.

Quentin N. Burdick Program for Rural Interdisciplinary Training (Section 754) provided

grants for interdisciplinary rural-focused health workforce training projects. This program has not

been funded in the past decade and does not have a current authorization of appropriations.

Allied Health and Other Disciplines (Section 755) authorizes grants to support allied health

professionals. This program has not been funded in recent years.

Health Workforce Information and Analysis (Section 761) established HRSA’s National

Center for Health Workforce Analysis and authorizes grant programs to support state, local, and

longitudinal workforce analyses. This program received an appropriation of $5.663 million in

FY2020.

The Council on Graduate Medical Education (COGME; Section 762) analyzes and reports to

relevant congressional committees on issues related to the physician workforce, training, and the

financing of training. The committee is authorized in Section 762, which lays out the committee

membership and its reporting requirements. The section also specifies that the committee was to

sunset in 2003; however, language in appropriations laws have waived this sunset date.119

Public Health Training Centers (Section 766) authorizes grants at public health schools to train

public health professionals in health promotion and preventive medicine, among other things.

This program receives its authorizations of appropriation in PHSA Section 770(a).

Authorization of Appropriations (Section 770) authorizes appropriations for the group of

public health workforce programs authorized in PHSA Sections 765-770. Public health workforce

programs received an appropriation of $17 million in FY2020.

Pediatric Subspecialty Loan Repayment Program (Section 775) authorizes loan repayment to

specific pediatric subspecialists (including behavioral health specialists) in exchange for a service

requirement in underserved areas. This program was created in the ACA but has never been

funded or implemented.

Provision

This section extends authorizations of appropriations for a number of sections in PHSA Title VII.

In each case, appropriations are authorized for each of FY2021-FY2025. The section reauthorizes

the health workforce diversity programs as follows:

$23.711 million for PHSA Section 736,

$51.470 million PHSA Section 740(a),

$1.19 million for PHSA Section 740(b), and

$15 million for PHSA Section 740(c).

The section also amends the date of a report on diversity in the health professions required in

PHSA Section 740(d) to require that the report is due to the appropriate congressional committees

not later than September 30, 2025, and every five years thereafter.

The section also amends and extends the authorizations of appropriations for a number of

programs related to primary care medical and dental training, as specified below.

119 For FY2020, this was included in Title II of Division A of P.L. 116-94.



The section amends PHSA Section 747, which authorizes training programs for

primary care physicians and physician assistants. The section makes the

following changes: (1) removes reference to demonstration projects in grants

related to innovative care models; (2) amends granting priorities to permit the

Secretary to give preference to qualified applicants that train residents in rural

areas, including for Tribes or Tribal Organizations that are located in rural areas;

(3) changes references from “substance-related disorders” to “substance use

disorders;”120 and (4) authorizes an appropriation of $48.294 million annually for

each of FY2021-FY2025.

The section amends PHSA Section 748, which authorizes training programs for

general, pediatric, and public health dentists and dental hygienists; it changes

references from “substance-related disorders” to “substance use disorders” and

authorizes an appropriation of $28.531 million for each of FY2021-FY2025.

The section amends PHSA Section 749(d), which authorizes the Advisory

Committee on Training in Primary Care Medicine and Dentistry, to update

references to congressional committees to reflect the current committee names.

The section amends PHSA Section 751, which authorizes the Area Health

Education Center program, to authorize an appropriation of $41.25 million for

each of FY2021-FY2025.

The section amends PHSA Section 754, which authorizes the Quentin N. Burdick

Program for Rural Interdisciplinary Training, to revise language related to using

grant funds by replacing “new and innovate” with “innovative or evidence-

based.”

The section amends in PHSA Section 755, which authorizes grants for training in

Allied Health and Other Disciplines to replace language related to the elderly

with reference to “geriatric populations or for maternal and child health.”

The section amends PHSA Section 761, which authorized Health Workforce

Information and Analysis, to authorize to be appropriated $5.663 million

annually for each of FY2021-FY2025.

The section amends PHSA Section 762 (COGME) to update references to

congressional committees to reflect the current committee names; change

language from the Health Care Financing Administration to CMS; make

conforming changes; add the HRSA Administrator to the council; delete language

related to reports required at COGME’s outset and the council’s termination; and

add new reporting requirement dates. Specifically, it requires a report to be

delivered to specified congressional committees not later than September 30,

2023, and not less than every five years thereafter.

The section amends PHSA Section 766 (Public Health Training Centers) to delete

language related to Healthy People 2000 and to add language related to rural

areas.

The section amends PHSA Section 770 (Authorization of Appropriations), which

authorizes appropriations for Public Health Workforce Programs, to authorize

$17 million to be appropriated for each of FY2021-FY2025.

120 CARES Act Section 3401, and other sections in the law, replace references to substance abuse with “substance use

disorders” to reflect contemporary terminology used in the field and align language in the law with the most current

version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).



The section amends PHSA Section 775 (Loan Repayment for Pediatric

Subspecialists) to authorize such sums as may be necessary for each of FY2021-

FY2025.

Section 3402. Health Workforce Coordination

Background

HRSA administers a number of health workforce programs through its Bureau of Health

Workforce. A number of these programs also have advisory committees that advise HRSA and

Congress about specific programs (e.g., the Advisory Committee on Training in Primary Care

Medicine and Dentistry provides oversight of programs authorized in Sections 747 and 748

related to primary care medicine and dental training).121 Each of these advisory groups has a

specific charge or scope, and their work is generally not coordinated. For example, although

COGME evaluates graduate medical education (GME) policy, the bulk of GME funding is from

CMS, while the relevant advisory group is administered through HRSA. Experts have

recommended the need for more coordinated GME and overall health workforce policy as a way

to better focus federal health workforce investments across the federal government.122

Provision

This section requires the Secretary, in consultation with the Advisory Committee on Training in

Primary Care Medicine and Dentistry and the COGME, to develop a comprehensive plan that

coordinates HHS’s health care workforce development programs. The plan must include certain

specified elements such as performance measures, as specified; gap analyses and plans to rectify

these gaps; and barriers to implementing strategies to rectify the identified gaps. It also requires

the Secretary to coordinate with other federal agencies and departments that administer relevant

education and training programs. The purpose of such coordination is to evaluate whether these

programs are meeting U.S. health workforce needs and identify opportunities to improve

information collected to better inform program improvements. Finally, the section requires the

Secretary to submit a report describing the comprehensive health workforce plan and its

implementation to specified congressional committees no later than two years after enactment.

Section 3403. Education and Training Relating to Geriatrics

Background

PHSA Section 753 authorizes a number of geriatric workforce programs. Separately, PHSA

Section 865 authorizes similar geriatric workforce programs focused on nurses, because nurses

are generally not eligible for programs in Title VII. Beginning in FY2015, HRSA opted to

consolidate and administer these geriatric workforce programs together and has since supported

two training programs: the Geriatrics Workforce Enhancement Program (GWEP) and the

Geriatrics Academic Career Awards (GACA).123 GWEP provides grants to create training

programs that focus on training inter-professional teams to increase geriatric competence among

121 For information on HRSA advisory committees, see HHS, HRSA, “Federal Advisory Committees,”

https://www.hrsa.gov/advisory-committees/index.html.

122 See discussion in CRS Report R44376, Federal Support for Graduate Medical Education: An Overview. See also

discussion of Sec. 5101 in CRS Report R41278, Public Health, Workforce, Quality, and Related Provisions in ACA:

Summary and Timeline.

123 HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2015,” pp. 136-143 and pp. 188-191.



primary care and other types of health care providers.124 GACA makes awards to institutions on

behalf of junior (non-tenured) faculty to support the career development of academic geriatricians

in medicine, pharmacy, nursing, social work, and other health professions. The expectation is that

GACA award recipients will provide inter-professional clinical training and become leaders in

academic geriatrics.

PHSA Section 753 was most recently reauthorized in the ACA, which added a number of new

subsections within the section that authorized new geriatric training programs. These new

programs were never implemented. Appropriations were authorized through FY2014, with the

exception of the Geriatric Career Incentive Award program, which had been authorized through

FY2013.125 Despite the lapsed authorization of appropriations, these programs have been funded

in recent years; most recently they received $40.737 million in FY2020. 126

Provision

This section replaces PHSA Section 753 with a new PHSA Section 753, “Education and Training

Related to Geriatrics.” The new section codifies two existing geriatric workforce training

programs: (1) GWEP and (2) GACA. It deletes existing unfunded geriatric training programs.

The section, in new subsection (a) requires the Secretary to award grants, contracts, or

cooperative agreements to specified health professional schools, including schools of allied

health, nursing schools, and programs that focus on geriatric education, to establish GWEPs. It

specifies the GWEP requirements that include health trainee support, and an emphasis on patient

and family engagement and primary care integration. The section also specifies the activities that

GWEP programs are authorized to provide, including specific types of training and Alzheimer’s

disease education. The section specifies that GWEP grants may not be awarded for more than five

years; that applicants must submit an application, as specified; and that the Secretary is required

to use certain awarding priorities but may also take into account specified awarding

considerations. Finally, with regard to the GWEP program, the section specifies grantee reporting

requirements, requires the Secretary to report to specified congressional committees not later than

four years after the enactment of Title VII Health Care Workforce Reauthorization Act of 2019

and every five years thereafter, and requires that the report be made publicly available.127

New PHSA Section 753(b) establishes the GACA grant program where grants are awarded to

eligible entities to support their geriatric careers. The section defines the entities eligible for

GACA awards, including nursing schools and the health professionals who are eligible to receive

support. The section also specifies that academics must be junior non-tenured faculty at the time

the award is made, but that they remain eligible for the award if they receive tenure during the

award period. The section specifies the application requirements and the assurances regarding

service requirements that the application must contain. It specifies that, when making awards, the

Secretary is required to ensure a geographical distribution among award recipients, including

among rural MUAs. The section also specifies that grants must be a minimum of $75,000 in

124 HHS, HRSA, “Justification of Estimates for Congressional Committees, FY2015,” https://ww.hrsa.gov/sites/default/

files/hrsa/about/budget/budget-justification-fy2021.pdf, p.122.


and Related Provisions in ACA: Summary and Timeline.


Committees, FY2021,” https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2021.pdf,

p.18.

127 The reference to the Title VII Health Care Workforce Reauthorization Act of 2019 appears to be a drafting error;

however, this provision was included, with changes to the authorization date and amounts, in S. 2997, Title VII Health

Care Workforce Reauthorization Act of 2019. See version of S. 2997, as reported to the Senate on December 17, 2019.



FY2021, to increase annually by the CPI thereafter; that award periods may not exceed five years;

and the service requirement that awardees must fulfill as a condition of receiving an award.

Finally, for both GWEP and GACA, the section waives certain awarding preferences that

otherwise apply to Title VII grants, and it authorizes to be appropriated $40.737 million for each

of FY2021-FY2025.

Section 3404. Nursing Workforce Development

Background

PHSA Title VIII authorizes a number of nursing workforce programs. Part A provides general

provisions of the title, including definitions and entities eligible for the grants made available

under the title. Part B authorizes grant programs to support advance practice nurses, including

nurse practitioners, nurse anesthetists, and nurse midwives. Part C authorizes grant programs that

seek to increase nursing workforce diversity, and Part D authorizes grant programs that aim to

strengthen the nursing workforce and improve nursing practice. This effort includes programs that

seek to expand the nursing career ladder whereby individuals in lower skilled health professions

receive training and education to advance in the nursing field (e.g., from a nursing assistant to a

registered nurse). Finally, Part E establishes the nursing student loan program. These programs

were most recently reauthorized in the ACA, with authorizations of appropriations through

FY2013 or FY2014.128 Despite the lapsed authorization, these programs have been funded in

recent years. Specifically, in FY2020, they received an appropriation of $260 million.129

Provision

This section reauthorizes programs in PHSA Title VIII in subsection (a), while subsection (b)

requires a GAO report on nursing loan programs.

General Provisions. Subsection (a) makes the following changes to Title VIII. It adds nurse-

managed health clinics to the definition of entities eligible for grants authorized in Title VIII;

adds new language to applications (in Section 802), to use of funds (in Section 803), and to

provisions that are generally applicable to Title VIII (Section 806). Specifically, the subsection

adds new language that grants should be awarded to address national nursing needs, as specified;

to require new information from grantees; and to add new language requiring a biennial report

that includes certain specified elements to be delivered not later than September 30, 2020, to

specified congressional committees. The subsection also makes a number of changes to Section

811 (grants for advance education nursing grants) to replace language that references master’s

level nurses to graduate level nurses, to change language referencing clinical nurse leaders to

nurse administrators, and to add that clinical nurse specialist programs, as specified, are eligible

for grants under this section.

Nurse Education, Quality, and Retention Grants. The subsection amends Section 831 to

rename the section “Nurse Education, Quality, and Retention Grants.” It also amends the

description of practice priority groups and retention priority areas within the nursing career ladder

by adding language, that among other things, specifies that grants help individuals, including

health aides or community health practitioners certified under the IHS Community Health Aide

Program, enter the nursing career ladder. It adds language to Section 831 specifying that grants


and Related Provisions in ACA: Summary and Timeline.


Committees, FY2021,” https://www.hrsa.gov/site.fault/files/hrsa/about/budget/budget-justification-fy2021.pdf, p. 18.



may be used to develop and implement fellowship and residency programs and to encourage the

mentoring and development of nursing specialties. It also deletes subsection (e), referring to grant

awards preferences in prior years, and (h), which had authorized appropriations from FY2010-

FY2014, and renumbers the subsection accordingly. The subsection also amends the reporting

requirements in Section 831 to require the Secretary to submit a report on the grants in this

section as part of a larger report required under Section 806, and expands the entities eligible for

grants under this section to add, in addition to nursing schools, health care facilities, Federally

Qualified Health Centers (FQHCs), nurse-managed health clinics, and a partnership of such a

school and facility.

Deletions. The subsection deletes PHSA Section 831A (Nurse Retention Grants), because grants

for this purpose are now included in the amended PHSA Section 831. It then amends PHSA

Section 846 (Loan Repayment and Scholarship Program) to permit individuals to fulfill their

service commitment and for-profit health facilities, to make language gender neutral, and to

remove the sections authorization of appropriation and make reference to an amount allocated

under PHSA Section 871(b). The section also deletes the separate authorization of appropriations

from PHSA Section 846A (Nurse Faculty Loans) and Section 847 (Eligible Individual Student

Loan Repayment); adds language referencing clinical nurse specialists to PHSA Section 851

(National Advisory Council on Nurse Education and Practice); amends the committees that the

council is required to report to update to current committee names; and amends language related

to amounts available to fund the council’s activities. The section also deletes PHSA Section 861

(Public Service Announcements) and PHSA Section 862 (State and Local Public Service

Announcements).

Appropriation Changes. Finally, the subsection amends Section 871, which authorizes

appropriations for the title to authorize $137.837 million for each of FY2021-FY2025 to carry out

Parts B, C, and D of Title VIII and to authorize $117.135 million for each of FY2021-FY2025 to

carry out Part E (Student Loan Funds).

Subsection (b) of the provision requires a GAO report that evaluates nurse loan repayment

programs, as specified, to be delivered to specified congressional committees, no later than 18

months after enactment.

Subtitle D—Finance Committee

Subtitle D makes a series of changes in the Medicare and Medicaid programs in response to the

COVID-19 public health emergency declared by the Secretary. The Medicare provisions increase

certain payments to providers, including hospitals; expand the use of allowable telehealth

services; make any potential COVID-19 vaccine available under Medicare Part B without cost-

sharing; and relax certain program requirements to make it easier for Medicare patients to obtain

certain services. The provisions also address cost-sharing to states for Medicaid services.

Section 3701. Exemption for Telehealth Services

Background

A health savings account (HSA) is a tax-advantaged account that individuals can use to pay for

unreimbursed medical expenses (e.g., deductibles, co-payments, coinsurance, and services not

covered by insurance).130

130 For more information on health savings accounts (HSAs), see CRS Report R45277, Health Savings Accounts

(HSAs).



Individuals are eligible to establish and contribute to an HSA if they have coverage under an

HSA-qualified high-deductible health plan (HDHP), do not have disqualifying coverage, and

cannot be claimed as a dependent on another person’s tax return.

To be considered an HSA-qualified HDHP, a health plan must meet several criteria: (1) it must

have a deductible above a certain minimum level, (2) it must limit out-of-pocket expenditures for

covered benefits to no more than a certain maximum level, and (3) it can cover only preventive

care services before the deductible is met.

For example, if a health plan satisfies the first two of the aforementioned criteria and provides

coverage for preventive care services and prescription drugs before the deductible is met, that

health plan would not be considered an HSA-qualified HDHP because it provides prescription

drug benefits before the deductible is met.

Disqualifying coverage is generally considered any other health coverage that is not an HSA-

qualified HDHP or that provides coverage for any benefit that is covered under their HSA-

qualified HDHP.

Provision

Section 3701 amends Internal Revenue Code (IRC) Section 223(c) for plan years beginning on or

before December 31, 2021, to allow HSA-qualified HDHPs to provide “telehealth and other

remote care services” before the deductible is met and still be considered an HSA-qualified

HDHP.

For plan years beginning on or before December 31, 2021, Section 3701 provides that telehealth

and other remote care would not be considered disqualifying coverage that would prevent an

otherwise eligible individual from being considered HSA-eligible.

These provisions were effective upon the date of enactment (i.e., March 27, 2020).

Section 3702. Inclusion of Certain Over-The-Counter Medical Products as

Qualified Medical Expenses

Background

There are four categories of health-related tax-advantaged accounts/arrangements: HSAs, Archer

medical savings accounts (Archer MSAs), flexible spending arrangements (FSAs), and health

reimbursement arrangements (HRAs). Distributions from HSAs and Archer MSAs and

reimbursements from FSAs and HRAs that are used to pay for qualified medical expenses are not

taxed.

Each account/arrangement category has a different set of medical expenses that would be

considered a qualified medical expense, but all accounts/arrangements generally consider, at a

minimum, the following as qualified medical expenses: the costs of diagnosis, cure, mitigation,

treatment, or prevention of disease and the costs for treatments affecting any part of the body; the

amounts paid for transportation to receive medical care; and qualified long-term care services.

Most recently, OTC medicines and drugs (other than insulin) were not considered a qualified

medical expense for any account/arrangement category unless an individual received a

corresponding prescription for each non-prescribed expense.

Provision

Section 3702 amends Sections 106, 220(d)(2)(A), and 223(d)(2) of the IRC to allow OTC

medicines and drugs (without a prescription) and menstrual care products to be considered



qualified medical expenses for HSAs, Archer MSAs, FSAs, and HRAs. This change in the

definition of qualified medical expenses applies to amounts paid or expenses incurred after

December 31, 2019.

Section 3703. Increasing Medicare Telehealth Flexibilities During

Emergency Period

Background

Medicare coverage under Part B (fee-for-service) for telehealth services is defined under SSA

Section 1834(m), which places certain conditions on such care, including who can furnish and be

paid for the service, where the patient is located (the originating site), where the physician is

located (the distant site), and the types of services that are covered. Recent legislation has

modified some of the conditions under which telehealth services may be furnished under

Medicare. The Coronavirus Preparedness and Response Supplemental Appropriations Act (P.L.

116-123) Division B, Section 102, added certain Medicare telehealth restrictions to the list of

applicable conditions for which the Secretary could temporarily waive or modify program

requirements or regulations during the COVID-19 emergency. The provision also defined a

qualified telehealth provider, requiring a prior relationship within the past three years between the

patient and the provider under Medicare. Subsequently, FFCRA Division F, Section 6010,

expanded the definition of a qualified provider to include those who had provider-patient

relationships within the past three years outside of Medicare.

Provision

Section 3703 removes the list of telehealth restrictions the Secretary was allowed to waive under

P.L. 116-123 and broadens the Secretary’s authority to temporarily waive any of the SSA Section

1834(m) telehealth requirements. The provision also removes the definition of a “qualified

provider” for telehealth services during the COVID-19 emergency period pursuant to SSA

Section 1135. The provision strikes the specific subsection added under P.L. 116-123 related to

telephone use, such that the waiver authority applies more broadly to include “a telehealth service

[…] furnished in any emergency area (or portion of such an area) during any portion of any

emergency period to an individual.” In addition, removing the “qualified provider” definition

eliminates the requirement of a prior relationship between the patient and the provider for

telehealth services to be delivered and covered under the COVID-19 emergency declaration.

Section 3704. Enhancing Medicare Telehealth Services for Federally Qualified

Health Centers and Rural Health Clinics During Emergency Period

Background

Under current law, FQHCs and rural health clinics (RHCs) are allowed to be originating sites for

covered telehealth services (sites where a patient is located) but are not allowed to be distant sites,

where physicians may provide telehealth services to eligible patients at other locations

(originating sites). Generally, both FQHC and RHCs are not paid under the Medicare physician

fee schedule (MPFS). Rather, FQHCs are paid through an FQHC-specific prospective payment

system (PPS), while RHCs are reimbursed as an all-inclusive rate for the services they provide.

Provision

Section 3704 allows FQHCs and RHCs to serve as distant sites for the furnishing of telehealth

services to telehealth-eligible individuals during the emergency period. The Secretary is required



to develop and implement, through program instruction or otherwise, payment methods for this

purpose that apply to FQHCs and RHCs serving as a distant sites that furnish telehealth services

to eligible telehealth individuals during such an emergency period. Such services are to be paid

similar to the national average amount for comparable telehealth services under the MPFS. The

costs associated with this care are not to be included when calculating the payments for the

FQHC PPS or the RHC all-inclusive rates, under current law.

Section 3705. Temporary Waiver of Requirement for Face-To-Face Visits Between

Home Dialysis Patients and Physicians

Background

Medicare is the main source of health care coverage for Americans with end-stage renal disease

(ESRD). Individuals with ESRD have substantial and permanent loss of kidney function and

require either a regular course of dialysis (a process that removes harmful waste products from an

individual’s bloodstream) or a kidney transplant to survive. Medicare covers beneficiaries aged

65 and older who have ESRD, as well as qualified individuals with ESRD who are under the age

of 65.131

Medicare ESRD benefits include thrice-weekly dialysis treatment and coverage for kidney

transplants. CMS pays physicians, typically nephrologists, and other practitioners a monthly per-

patient rate for most dialysis-related services. Physicians and practitioners managing ESRD

patients who perform home-based dialysis are paid a single monthly rate based on the ESRD

beneficiary’s age. A physician or practitioner is required to have at least one face-to-face visit

with a home dialysis patient each month.132

As part of the Bipartisan Budget Act of 2018 (BBA 2018; P.L. 115-123), Congress expanded the

use of telehealth services for ESRD patients undergoing home dialysis. Starting in 2019, ESRD

beneficiaries who use home dialysis have been allowed to receive monthly face-to-face clinical

assessments via telehealth services, so long as the beneficiaries receive a face-to-face assessment

without the use of telehealth (1) at least monthly for the initial three months of home dialysis, and

(2) after the initial three months, at least once every three consecutive months.

Provision

Section 3705 amends SSA Section 1881(b)(3)(B) to allow the Secretary to waive the requirement

that to receive telehealth services, a Medicare ESRD beneficiary undergoing home dialysis

receive a face-to-face clinical assessment from a practitioner monthly during the initial three

months of home dialysis and once every three months thereafter. The requirement may be waived

for the period that the COVID-19 emergency is in effect.

Section 3706. Use of Telehealth to Conduct Face-To-Face Encounter Prior to

Recertification of Eligibility for Hospice Care During Emergency Period

Background

The Medicare hospice benefit provides coverage for certain services provided to Medicare

beneficiaries with a life expectancy of six months or less. Such services must be rendered by

131 Social Security Amendments of 1972; P.L. 92-603.

132 CRS Report R45290, Medicare Coverage of End-Stage Renal Disease (ESRD).



Medicare-certified hospices, which are either public agencies or private organizations primarily

engaged in providing hospice services.

Although beneficiaries who elect hospice care may disenroll from the hospice benefit at any time,

the benefit is administratively structured by “periods”: specifically, two 90-day periods and an

unlimited number of subsequent 60-day periods. For hospice care to be covered under Medicare,

an initial certification of a terminal illness must be obtained by the hospice at the beginning of the

first 90-day period of care. The initial certification requires signed declarative statements attesting

to the presence of a terminal illness by the hospice physician and the beneficiary’s attending

physician, if the individual has designated one. For each subsequent period of hospice care,

recertification of the beneficiary’s terminal illness is required only by the hospice physician.

Since the beginning of 2011, part of the recertification process to determine continued eligibility

has included a mandatory face-to-face encounter with the beneficiary by the hospice physician or

nurse practitioner.

Provision

Section 3706 amends SSA Section 1814(a)(7)(D)(i) to provide that, as determined appropriate by

the Secretary, a hospice physician or nurse practitioner may conduct a face-to-face encounter for

continued eligibility purposes via telehealth during a period that the COVID-19 emergency is in

effect.

Section 3707. Encouraging Use of Telecommunications Systems for Home Health

Services Furnished During Emergency Period

Background

Medicare covers visits by participating home health agencies for beneficiaries who (1) are

confined to home and (2) need either skilled nursing care on an intermittent basis, physical

therapy, or speech language therapy. As required by SSA Section 1895, home health agencies are

paid for services under a home health PPS based on 30-day episodes of care. Generally, the home

health PPS consists of a nationwide payment amount that is subject to adjustments for the

expected care needs of a beneficiary (i.e., case-mix) and differences in local wages. Further

payment adjustments are made in certain situations, including a low-utilization payment

adjustment (LUPA) for episodes of care with few home visits.133

Under SSA Section 1895, home health agencies are not precluded from adopting telemedicine or

other technologies, but such services are not permitted to serve as a substitute for visits paid

under the home health PPS. Accordingly, federal regulations define a home health visit as an

episode of personal contact. As such, telemedicine services are not accounted for in the home

health PPS, nor do providers receive direct payment for telemedicine services generally.

Although there is no direct payment for home health services provided through remote

technologies, regulations in 42 C.F.R. Part 409.46 designate remote patient monitoring as a

service with costs that may be reported as administrative if remote patient monitoring is used to

augment the care planning process. Remote patient monitoring is defined in regulations as the

collection of patient health information that is digitally stored or transmitted by the patient and/or

caregiver to the home health agency. CMS allows home health agencies to include the costs of

remote patient monitoring as an allowable administrative cost.

133 CRS Report R40425, Medicare Primer.



Provision

Section 3707 requires the Secretary to consider how HHS can encourage the use of telemedicine

by home health agencies with respect to home health services provided to Medicare beneficiaries

during the period that the COVID-19 emergency is in effect. Specifically, the Secretary is

required to consider ways to encourage the use of telecommunications systems, including for

remote patient monitoring, and other communications or monitoring services. Use of new

technologies must be consistent with the plan of care for beneficiaries. As part of this

consideration, the Secretary may clarify guidance and conduct outreach, as appropriate.

Section 3708. Improving Care Planning for Medicare Home Health Services

Background

Medicare covers certain home health services under both Parts A and B.134 Special eligibility

requirements and benefit limits exist for home health services furnished under Part A to

beneficiaries who are enrolled in both Parts A and B. For such beneficiaries, Part A pays for only

“postinstitutional” home health services, provided for up to 100 visits during a “spell of illness,”

which is a period that extends 14 days after a discharge from a skilled nursing facility or a

hospital following a minimum stay of three consecutive days. Part B covers any medically

necessary home health services that exceed the 100-visit limit, as well as medically necessary

home health services that do not qualify as “postinstitutional.”

For beneficiaries enrolled in only Part A or Part B, the requirements described above do not apply.

Part A or Part B, as applicable, covers all medically necessary episodes of home health care

without a visit limit, regardless of whether the episode of care follows a hospitalization. Whether

a beneficiary is enrolled in Part A only, Part B only, or in both, the scope of the Medicare home

health benefit is the same. Medicare’s payments to home health agencies are calculated using the

same methods, and beneficiaries have no cost-sharing.

As required under SSA Sections 1814 and 1835 (for Parts A and Part B, respectively), for a

beneficiary to receive home health services under Medicare, certain eligibility requirements must

be certified by a physician, including a face-to-face encounter performed by a physician or a

specified medical professional working in collaboration with, or under the supervision of, the

physician, as applicable. For a beneficiary to be eligible for coverage, the physician certifies that

home health services are required because the beneficiary, under the care of the physician, is (1)

confined to the home and (2) in need of either skilled nursing care on an intermittent basis,

physical therapy, or speech language therapy. After this eligibility is established, the eligibility

period may be continued for homebound beneficiaries with a certified continuing need for

occupational therapy services.

A physician is prohibited from certifying home health eligibility if he or she has a significant

ownership interest in, or a significant financial or contractual relationship with, the home health

agency in which the services are to be provided. These conditions are delineated in federal

regulations and include an authorized exception for instances in which there is a solitary

community home health agency.

BBA 2018, Section 51002, amended SSA Sections 1814 and 1835 to expand the scope of

supporting documentation the Secretary may use to document Medicare eligibility for home

health services. Under the BBA changes, in addition to using a physician’s medical record or a

134 For more information on the Medicare program, including the services covered under each part, see CRS Report

R40425, Medicare Primer.



record compiled by an acute/post-acute facility, the Secretary may also use a home health

agency’s medical record as appropriate to the case involved.

Provision

Section 3708 amends SSA Section 1814(a)(2)(C) and Section 1835(a)(2)(A) to allow, no later

than six months after enactment, a nurse practitioner, clinical nurse specialist, or physician

assistant to certify the eligibility requirements for Medicare home health services under Parts A

and B, respectively. Section 3708 further allows a nurse practitioner, clinical nurse specialist, or

physician assistant to conduct the required face-to-face encounter that is part of the certification

process.

Section 3708 also amends SSA Sections 1814 and 1835 to prohibit such professionals with a

significant financial stake in a home health agency from certifying beneficiary eligibility when

that agency is the entity providing the necessary services. However, the same exemption exists as

the one pertaining to certifying physicians: the prohibition is waived if the servicing entity is the

sole community home health agency. Further, Section 3708 conforms to language in the BBA

2018 to allow the Secretary to use a home health agency’s medical record, in addition to a

medical record compiled by medical professionals with certification authority, to document

eligibility as appropriate to a specific case.

Section 3708 also amends SSA Sections 1861 and 1895 to ensure that the general definitions of

home health services, coverage, and payment system encompass and conform with current

statutory language referencing the medical professionals to whom certification authority is

extended. In addition, amendments made under Section 3708 are applied under SSA Title XIX

(Medicaid) in the same manner and to the same extent such requirements apply to Medicare

under SSA Title XVIII or regulations promulgated thereunder.

No later than six months after enactment, the Secretary is required to implement regulations

relevant to application of the amendments. If necessary, the Secretary must produce an interim

final rule to comply with the required six-month effective date.

Section 3709. Adjustment of Sequestration

Background

The Budget Control Act of 2011 (BCA; P.L. 112-25) provided for increases in the debt limit and

established procedures designed to reduce the federal budget deficit, including the creation of the

Joint Select Committee on Deficit Reduction. The failure of the Joint Committee to propose

deficit reduction legislation that was subsequently enacted into law by its mandated deadline

triggered automatic spending reductions, including the “sequestration” (i.e., across-the-board

reductions) of mandatory spending in FY2013 through FY2021. Subsequent legislation extended

the sequestration of mandatory spending through FY2029. Medicare benefits are funded through

mandatory spending and are subject to reductions under such sequestration.135

Section 256(d) of the Balanced Budget and Emergency Deficit Control Act of 1985 (BBEDCA;

P.L. 99-177) contains special rules for the Medicare program in the event of a sequestration.

Among other things, it specifies that for Medicare, sequestration is to begin the month after the

annual sequestration order has been issued and to continue for one calendar year. Subsequent

sequestration orders begin the first month after the previous order ends. Therefore, as the initial

135 For additional information, see CRS Report R45106, Medicare and Budget Sequestration.



sequestration order was issued March 1, 2013, Medicare sequestration began April 1, 2013, and

was (most recently) scheduled to continue through March 31, 2030.

Under a BCA mandatory sequestration order, Medicare benefit payments cannot be reduced by

more than 2%. Since April 1, 2013, Medicare benefit-related payments, which include payments

to health care providers, Medicare Advantage (MA), and Part D plans, have been subject to 2%

reductions.

Provision

This provision waives the application of sequestration to the Medicare program for the period

May 1, 2020, through December 31, 2020.

This provision also extends the sequestration of mandatory spending for an additional year,

through FY2030. (For Medicare, this means that sequestration will continue through March 31,

2031.)

Section 3710. Medicare Hospital Inpatient Prospective Payment System Add-On

Payment for COVID-19 Patients During Emergency Period

Background

Medicare pays most acute care hospitals under the inpatient prospective payment system

(IPPS).136 The IPPS payment is a predetermined, fixed amount for most services provided to a

Medicare beneficiary during an inpatient hospital stay. The bundled, fixed, per-discharge portion

of the IPPS is referred to as the IPPS base amount. The total IPPS payment is the base amount,

adjusted by a number of factors. These adjustments generally include such things as the

geographic location of the hospital, the complexity of the patient’s condition, and a hospital’s

teaching status, among others. One of the adjustments is a payment weight associated with the

Medicare severity-diagnosis related group (MS-DRG) to which a patient is assigned. This weight

reflects the average cost of patients in a specific MS-DRG relative to the average cost across all

MS-DRGs due to differences in the severity of patients’ conditions. In FY2020, there are 759

MS-DRGs (i.e., codes). The MS-DRG weights are recalibrated annually, generally effective

October 1 of each year. The recalibrations are done in a budget-neutral manner.

Provision

Section 3710 amends SSA Section 1886(d)(4)(C) to require the Secretary to increase the MS-

DRG weight that would otherwise apply for a COVID-19-related Medicare discharge by 20%

during the COVID-19 emergency period. IPPS payment increases associated with this provision

are not to be included in applying budget neutrality. The Secretary is not required to use notice

and comment to implement this provision; it may be done through program instruction or

otherwise. A state that has a Section 1115A waiver of all or part of SSA Section 1886 to test

alternative payment and delivery models through the Center for Medicare & Medicaid Innovation

is not precluded from implementing a similar payment adjustment.137

Section 3711. Increasing Access to Post-Acute Care During Emergency Period

Background

136 See CRS Report R40425, Medicare Primer.

137 42 U.S.C. §1315a(d)(1).



Medicare pays for intensive inpatient rehabilitation services—physical, occupational, or speech

therapy that is generally required after illness, injury or surgery—under the Inpatient

Rehabilitation Facility (IRF) prospective payment system (IRF PPS). The IRF PPS payment is a

predetermined, fixed amount per discharge. To receive the IRF PPS payment, the rehabilitation

hospital, or a rehabilitation unit within another provider type, must meet IRF requirements

specified in regulation. Medicare covers IRF services for patients who, among other

requirements, can reasonably be expected to actively participate in, and benefit from, intensive

rehabilitation therapy. Intensive rehabilitation therapy is specified in regulation as occurring

either 3 hours a day at least five days per week, or 15 hours within a consecutive seven-day

period.

Medicare also pays for extended periods of inpatient hospital care for chronic critical illness

under the long-term care hospital inpatient prospective payment system (LTCH PPS). The LTCH

PPS payment is a predetermined, fixed amount per discharge, and it is generally greater than the

IPPS amount. Specifically, LTCHs are paid under the LTCH PPS if a Medicare beneficiary either

(1) had a prior three-day intensive-care-unit stay at a hospital paid under the IPPS immediately

preceding the LTCH stay, or (2) is assigned to an LTCH PPS case-mix group that is based on the

receipt of ventilator services for at least 96 hours, and had a prior hospital stay at a hospital paid

under the IPPS immediately preceding the LTCH stay. LTCH discharges occurring in FY2020,

and subsequent fiscal years that do not meet the aforementioned criteria are paid a site-neutral

payment rate similar to the IPPS amount. Also, an LTCH must have no more than 50% of its

Medicare discharges paid at the site-neutral rate to continue to receive the LTCH PPS payment

amount for LTCH-eligible cases.

Provision

Section 3711(a) waives the Medicare IRF rule that patients must reasonably be expected to

participate in, and benefit from, at least 15 hours of therapy per week, during the COVID-19

emergency period. Section 3711(b) waives the site-neutral payment requirement for COVID-19-

related LTCH discharges so that all these discharges will be paid under the LTCH PPS, and it

waives the 50% requirement during the during the COVID-19 emergency period.

Section 3712. Revising Payment Rates for Durable Medical Equipment Under the

Medicare Program Through Duration of Emergency Period

Background

Medicare Part B covers a wide variety of medical equipment and devices under the heading of

durable medical equipment (DME),138 or prosthetics and orthotics (PO)139 if the products are

medically necessary and prescribed by a physician. Examples of DME include hospital beds,

blood glucose monitors, and ventilators.140 Prosthetics and orthotics include artificial limbs and

back and knee braces. The DMEPOS benefit also includes related supplies (S), such as drugs and

biologics that are necessary for the effective use of a product.

138 Durable medical equipment (DME) is equipment that (1) can withstand repeated use, (2) has an expected life of at

least three years (effective for items classified as DME after January 1, 2012), (3) is used primarily to serve a medical

purpose, (4) is not generally useful in the absence of an illness or injury, and (5) is appropriate for use in the home.

139 Prosthetics (P) are items that replace all or part of a body organ or its function. Orthotics (O) are braces that support

a weak or deformed body member, such as leg or back braces.

140 The Medicare DME benefit applies to equipment that is to be used in the home. Generally, equipment that is to be

used during a hospital inpatient stay is paid under Part A.



Except in competitive bidding areas,141 Medicare pays for most DMEPOS based on fee schedules,

which are statutory formulas for determining prices of items. Medicare pays 80% of the lower of

a supplier’s charge for an item or a fee schedule amount. A beneficiary is responsible for the

remaining 20%. In general, fee schedule amounts are updated each year, by inflation and a

measure of economy-wide productivity.

In addition, since 2016, Medicare fee schedule rates that apply outside of competitive bidding

areas for certain DMEPOS142 have been reduced based on price information collected from the

competitive bidding program. (Prices for DMEPOS under competitive bidding are generally

lower than the fee schedule rates.) The fee schedule reductions were phased in during 2016,

meaning that during that year, 50% of the Medicare payment rate was based on the unadjusted

(higher) fee schedule amount, and 50% was based on the (lower) rate fully adjusted with

information from competitive bidding. The phase-in was complete by January 2017, at which

time fee schedules were based entirely on the adjustment with information from competitive

bidding. In response to concerns that the adjusted rates were too low, the Secretary, in June 2018,

again applied a phase-in methodology for rural and noncontiguous areas, meaning that in these

areas the fee schedule was no longer fully adjusted by competitive bidding data, but instead went

back to a 50/50 blend of rates based on both (higher) unadjusted fee schedule rates and (lower)

rates fully adjusted by competitive bidding information.143

As such, two different fee schedules apply to DMEPOS products outside of competitive bidding

areas, depending on an area’s rural/urban designation and whether an area is part of the

contiguous United States. First, in rural or noncontiguous areas, the fee schedule is a 50/50 blend:

50% from the unadjusted fee schedule and 50% from the fee schedule adjusted to account for

lower price information from competitive bidding (i.e., the phase-in methodology). Second, in

areas that are not rural or noncontiguous (i.e., nonrural and contiguous), the fee schedules are

fully adjusted by information from the competitive bidding program. In both cases, CMS

regulations specify that this methodology applies from June 1, 2018, through December 31, 2020.

Provision

Section 3712 of the CARES Act extends the 50/50 blended DMEPOS payment rate provided in

rural or noncontiguous areas through the duration of the COVID-19 emergency period, if the

emergency period lasts longer than December 31, 2020.

Section 3712 also increases the DMEPOS payment rate for items provided in areas other than

rural areas and noncontiguous areas for the duration of the COVID-19 emergency period. Items

and services furnished in these areas on or after the date that is 30 days after the enactment of the

CARES Act (i.e., April 26, 2020) would be reimbursed under a fee schedule that is equal to a

75/25 blend, where 75% of the fee schedule is fully adjusted by competitive bidding rates, and

25% is based on unadjusted (higher) fee schedule amounts.144

141 The Medicare Modernization Act (MMA, P.L. 108-173) required the Secretary to establish a Competitive

Acquisition Program for certain DMEPOS in specified areas. Instead of paying for medical equipment based on a fee

schedule established by law, payment for items in competitive bidding areas was based on supplier bids. The program

started in 9 metropolitan areas in January 2011 and had expanded to 130 competitive bidding areas in 2018. However,

the program was suspended to redesign and implement a new program methodology, which is slated to apply to

Medicare rates paid beginning January 1, 2021.

142 Not all DMEPOS are subject to competitive bidding, and as a result, the fee schedule amounts for noncompetitively

bid items cannot be reduced based on competitive bidding.

143 The noncontiguous areas are Alaska, Hawaii, and the territories.

144 The provision indicates that the Secretary is required to apply the regulations at 42 C.F.R. 414.210(g)(9)(iv), which



Section 3713. Coverage of the COVID-19 Vaccine Under Part B of the Medicare

Program Without Any Cost-Sharing

Background

Medicare Part B specifically covers the following vaccines: influenza virus (flu), pneumococcal

pneumonia (pneumonia), hepatitis B virus (HBV) for beneficiaries at high or intermediate risk,

and other vaccines directly related to treatment of an injury or direct exposure to a disease or

condition.145 Otherwise, Medicare Part B does not cover preventive vaccines.146 If a vaccine is

provided by a Medicare-participating practitioner, there is no cost-sharing for Medicare

beneficiaries for the flu, HBV, or pneumonia vaccine ingredient or the vaccine administration.

However, Medicare Part B cost-sharing applies (20% of the Medicare approved amount plus an

annual deductible) for vaccines administered to treat an injury or direct exposure to a disease or

condition.

Medicare Part C (MA) plans generally are required to cover the same services as original

Medicare, Parts A and B. As a result, MA plans are required to cover, without beneficiary cost-

sharing, the flu, HBV, and pneumonia vaccines. MA plans may cover without beneficiary cost-

sharing vaccines directly related to treatment of an injury or direct exposure to a disease or

condition and other vaccines. MA enrollee cost-sharing for vaccines not covered by Medicare

Part B may vary depending on the plan and the vaccine, because they may be covered as

supplemental benefits.

Provision

Section 3713 amended SSA Section 1861(s)(10)(A) and SSA Section 1852(a)(1)(B) to require

Medicare Part B and MA plans to cover a COVID-19 vaccine and its administration without

beneficiary cost-sharing, including waiving applicable annual deductibles. This section was

effective upon enactment (i.e., March 27, 2020) and is applicable to a COVID-19 vaccine on the

date it is licensed by FDA. The Secretary is authorized to implement Section 3713 through

program instructions or otherwise.

Section 3714. Requiring Medicare Prescription Drug Plans and MA-PD Plans to

Allow During the COVID-19 Emergency Period for Fills and Refills of Covered

Part D Drugs for Up to a 3-Month Supply

Background

Medicare Part D is a voluntary outpatient prescription drug benefit. Enrollees purchase Part D

prescription drug plans from private insurers, known as plan sponsors. To participate in the Part D

refers to payment phase-in methodology for nonrural and contiguous areas from June 1, 2018, through December 31,

2020 (i.e., the 100% phase-in), as if it were instead a reference to “dates of service from March 6, 2020, through the

remainder of the duration of the emergency period.” However, it is unclear what the March 6, 2020 date refers to.

145 For example, an anti-rabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin sera, or

immune globulin vaccination would be covered if beneficiaries were exposed to the condition or as a result of an

injury. However, without an injury or direct exposure, preventive vaccinations against diseases such as smallpox, polio,

and diphtheria are not covered under Medicare Part B. When a vaccine is not covered under Part B, related charges,

such as a charge for administering the vaccine, also are not covered.

146 Prescription drug plans that participate in Medicare’s voluntary outpatient prescription drug benefit under Part D are

required to cover all commercially available vaccines except those already covered by Medicare Part B, if the vaccines

are reasonable and necessary to prevent illness.



program, plan sponsors must meet a series of requirements, including (1) providing an adequate

formulary, or list of covered drugs, and (2) providing a sufficient network of contracted

pharmacies that dispense prescriptions for set reimbursement. Federal law also requires that Part

D sponsors provide enrollees with “adequate emergency access” to needed drugs.147 Under

longstanding CMS guidance, plan sponsors have some latitude in deciding how to comply with

the emergency access provisions.148 In general, however, CMS expects plan sponsors to limit

pharmacy edits (i.e., dispensing restrictions) that prevent enrollees from seeking early

prescription refills in the case of a federally declared disaster or a public health emergency that is

reasonably expected to disrupt access.149

In a March 10, 2020, memo to Part D sponsors, CMS reiterated its emergency access guidelines

and outlined options for responding to the COVID-19 emergency.150 In the memo, CMS specified

actions that Part D sponsors may or must take:

Sponsors may relax “refill-too-soon” edits on prescriptions if circumstances are

reasonably expected to result in a disruption in access. Sponsors have discretion

regarding how to relax the edits, so long as enrollees have access to Part D drugs

at the point-of-sale (i.e., a retail pharmacy). Sponsors may allow an enrollee to

obtain the maximum extended-day supply available under his or her plan, if the

prescription is requested and available.

Sponsors must ensure that an enrollee has adequate access to covered drugs at a

pharmacy located out of the enrollee’s regular pharmacy network. The

requirement would apply in cases where an enrollee could not reasonably be

expected to obtain the drugs at a network pharmacy. Enrollees would still be

responsible for required cost-sharing and possible additional charges (i.e., the

out-of-network pharmacy’s usual and customary charge for the drugs).151

Sponsors may relax plan-imposed policies that could discourage certain types of

prescription delivery, such as mail or home delivery, if a disaster or emergency

makes it difficult for enrollees to get to a retail pharmacy, or when enrollees are

prohibited from going to a retail pharmacy (such as in a quarantine situation).

Sponsors may waive requirements that enrollees receive prior authorization

before filling a prescription for drugs used to treat or prevent COVID-19, if or

147 (SSA 1860D-4(b)(1)(C)(iii))

148 Center for Medicare & Medicaid Services (CMS), Medicare Prescription Drug Benefit Manual, Chapter 5,

“Benefits and Beneficiary Protection,” Section 50.12, Rev. September 20, 2011, at http://www.cms.gov/Medicare/

Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/MemoPDBManualChapter5_093011.pdf. In

2014, CMS proposed more uniform requirements regarding emergency access but did not finalize a proposed rule on

the topic. CMS, “42 CFR Parts 417, 422, 423, et al. Medicare Program; Contract Year 2015 Policy and Technical

Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Final Rule,” Federal

Register, May 23, 2014, p. 29939.

149 In 2014, CMS proposed more uniform requirements regarding emergency access but did not finalize a proposed rule

on the topic. CMS, “42 CFR Parts 417, 422, 423, et al. Medicare Program; Contract Year 2015 Policy and Technical

Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Final Rule,” Federal

Register, May 23, 2014, p. 29939.

150 CMS, Memo to Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans, “Information

Related to Coronavirus Disease 2019 - COVID-19,” March 10, 2020, https://www.cms.gov/files/document/hpms-

memo-covid-information-plans.pdf.

151 Consistent with 42 C.F.R. 423.124(a).



when such drugs are identified. Any plan waivers would be provided to enrollees

uniformly.

Part D plan sponsors also operate drug management programs for beneficiaries deemed to be at

risk of misusing or abusing frequently abused drugs. Sponsors may place additional controls on

pharmacy dispensing to such individuals, including placing limits on the number of providers

allowed to write prescriptions for at-risk enrollees and limiting the number of pharmacies allowed

to dispense drugs to such enrollees. Under CMS regulations, at-risk enrollees must have

reasonable access to prescriptions in case of natural disasters or similar situations.152

Provision

Section 3714 amends SSA 1860D–4(b) to require Part D sponsors to provide extended dispensing

to enrollees during the COVID-19 emergency period. Under the provision, Part D sponsors must

allow an enrollee to have access to up to a 90-day fill or refill of a prescription. Plan sponsors

cannot deny such prescriptions based on existing plan cost and utilization management

requirements that limit dispensing of particular drugs, except for restrictions based on drug safety.

The Secretary may implement the provision by program instruction or otherwise.

Section 3715. Providing Home and Community-Based Services in Acute

Care Hospitals

Background

Medicaid home and community-based services (HCBS) include coverage of specific benefits

such as case management, personal care, homemaker, respite care, and adult day health care,

among other services. Medicaid HCBS are authorized under the Medicaid state plan, which is the

contract a state makes with the federal government to administer its Medicaid program, subject to

CMS approval.153 These HCBS state plan authorities include optional services that states may

choose to provide under the SSA Section 1915(i) HCBS State Plan Option, the SSA Section

1915(k) Community First Choice State Plan Option, and SSA Section 1915(j) Self-Directed

Personal Care Assistance Services. Medicaid HCBS are also authorized through waiver programs

that permit states to disregard certain Medicaid requirements under the state plan in the provision

of waiver services, also subject to CMS approval. Medicaid HCBS waiver authorities include

SSA Section 1915(c) HCBS waivers, SSA Section 1915(d) HCBS waivers for the elderly,154 and

SSA Section 1115 research and demonstration waivers.

SSA Section 1902(h) states that nothing in Title XIX (Medicaid) should be construed as

authorizing the Secretary to limit the amount of payment that may be made under a Medicaid

state plan for home and community care.155

Provision

Section 3715 amends SSA Section 1902(h) by adding a new paragraph (1) to specify that the limit

on the amount of payment under a Medicaid state plan for home and community care applies to

152 42 C.F.R. 423.153(f) (11) and (12).

153 For more information about Medicaid coverage of home and community-based services, see CRS Report R43328,

Medicaid Coverage of Long-Term Services and Supports.

154 According to CMS, no state has elected to use this waiver authority. CMS, “Medicaid Program; State Plan Home

and Community-Based Services, 5-Year Period for Waivers, Provider Payment Reassignment, and Setting

Requirements for Community First Choice; Proposed Rule,” 77 Federal Register 26367, May 3, 2012.

155 42 U.S.C. §1396a.



certain statutory authorities for providing Medicaid HCBS under state plan services authorized

under SSA Section 1915(i), Section 1915(j), and Section 1915(k), as well as waiver authorities

under Section 1915(c), Section 1915(d), and Section 1115.

The provision adds a new paragraph (2), which states that nothing in SSA Titles XI (General

Provisions), XVIII (Medicare), or XIX (Medicaid) shall be construed as prohibiting receipt of any

care or services specified in paragraph (1) in an acute care hospital that are identified in an

individual’s person-centered service plan (or comparable plan of care); provided to meet needs of

the individual that are not met through the provision of hospital services; not a substitute for

services that the hospital is obligated to provide through its conditions of participation or under

federal or state law, or under another applicable requirement; and designed to ensure smooth

transitions between acute care settings and home and community-based settings, and to preserve

the individual’s functional abilities.

Section 3716. Clarification Regarding Uninsured Individuals

Background

FFCRA Section 6004 permits state Medicaid programs to extend time-limited COVID-19 testing

(as specified under that law’s new Medicaid mandatory service category) without cost-sharing to

uninsured individuals. For the purposes of this provision, FFCRA Section 6004 defines uninsured

individuals as those who are not Medicaid eligible under one of Medicaid’s mandatory eligibility

pathways (e.g., the poverty-related pregnant women and child pathways, or the ACA Medicaid

expansion pathway),156 and are not enrolled in (1) a federal health program (e.g., Medicare,

Medicaid, CHIP, or TRICARE); (2) a specified type of private health insurance plan (e.g.,

individual health insurance coverage, group health insurance coverage, or a group health plan); or

(3) an FEHBP. FFCRA provides a 100% federal medical assistance percentage (FMAP or federal

matching rate) for medical assistance and administrative costs associated with uninsured

individuals who are eligible for Medicaid under this provision.

Provision

Section 3716 of the CARES Act amends the definition of uninsured individuals under FFCRA

Section 6004 for the purposes of determining Medicaid eligibility for the state plan option to

allow for time-limited COVID-19 testing (as specified under the new Medicaid mandatory

service category) without cost-sharing. Under the CARES Act, uninsured individuals will also

include those (1) who would be eligible for Medicaid via the ACA Medicaid expansion pathway

in states that have not adopted this eligibility pathway (i.e., non-ACA Medicaid expansion states),

and (2) certain specified Medicaid enrollees who, by virtue of their Medicaid eligibility pathway,

are entitled to limited Medicaid benefits, including

low-income tuberculosis-infected individuals who are entitled to services related

to the tuberculosis infection,

women needing treatment for breast or cervical cancer,

individuals eligible only for family planning services and supplies,

156 For more information on Medicaid eligibility, see CRS Report R43357, Medicaid: An Overview.



individuals eligible through the Medically Needy pathway157 whose coverage

does not meet minimum essential health coverage,158 and

certain low-income pregnant woman who are entitled to limited pregnancy-

related services.

Section 3717. Clarification Regarding Coverage of COVID-19 Testing Products

Background

FFCRA Section 6004 added FDA-approved tests and testing-related state plan services for the

COVID-19 virus without cost-sharing, as defined in Section 6004 to the list of Medicaid

mandatory services under traditional Medicaid benefits. States and territories are required to offer

services under this new mandatory benefit for the period beginning March 18, 2020, through the

duration of the public health emergency, as declared by the Secretary pursuant to PHSA Section

319. During the specified public health emergency period, Section 6004 of FFCRA also permits

state Medicaid programs to extend FDA-approved COVID-19 testing (and testing-related state

plan services) to uninsured individuals without cost-sharing, as defined in Section 6004 and

requires CHIP programs to cover FDA-approved COVID-19 testing and the administration of

such testing without cost-sharing for CHIP enrollees.

Section 6004 also amended SSA Section 1905(a)(3) to define applicable tests to include IVDs, as

defined in FDA regulation, that detect SARS-CoV-2159 or diagnose COVID-19 and that had

received either 510(k) clearance, premarket approval, authorization pursuant to de novo

classification, or emergency use authorization (EUA) for marketing.

Provision

The CARES Act modifies the definition of COVID-19 tests covered under Medicaid and CHIP

for the specified public health emergency period. Specifically, Section 3717 amends SSA Section

1905(a)(3)(B), as added by FFCRA Section 6004, to remove language requiring FDA approval,

clearance, or authorization for covered tests. Under this modified definition, tests are defined

simply as IVDs, as defined in FDA regulation, that detect SARS-CoV-2 or diagnose COVID-19.

IVDs are defined in FDA regulation as a specific subset of devices that include “reagents,

instruments, and systems intended for use in the diagnosis of disease or other conditions ... in

order to cure, mitigate, treat, or prevent disease ... [s]uch products are intended for use in the

collection, preparation, and examination of specimens taken from the human body.”160

157 Medically needy individuals (e.g., children, pregnant women, aged, blind, or disabled) are individuals who are

otherwise eligible for Medicaid but who have incomes too high to qualify and spend down their income on medical

care. For this medically needy subgroup, states may offer a more restrictive benefit package than is available to other

enrollees.

158 For more information on the CMS criteria used to evaluate if a given state’s medically needy coverage meets the

minimum essential health coverage standard, see CMS, Dear State Health Official, Dear State Medicaid Director,

SHO# 14-002, Re: Minimum Essential Coverage, November 7, 2014, https://www.medicaid.gov/sites/default/files/

Federal-Policy-Guidance/downloads/SHO-14-002.pdf. For more general information on minimum essential coverage

under Medicaid, see https://www.medicaid.gov/medicaid/eligibility/minimum-essential-coverage/index.html.

159 SARS-CoV-2 is the technical name of the virus that causes COVID-19 disease.

160 21 C.F.R. §809.3(a).



Section 3718. Amendments Relating to Reporting Requirements With Respect to

Clinical Diagnostic Laboratory Tests

Background

Outpatient clinical laboratory services are paid under the Medicare Clinical Laboratory Fee

Schedule (CLFS). Previously, CLFS payment rates were based on historical laboratory charges.

The Protecting Access to Medicare Act (PAMA, P.L. 113-93) established a new method for

determining clinical laboratory payments beginning in 2018, with Medicare CLFS payment rates

based on reported private insurance payment amounts.

Per PAMA, CMS was to collect data from clinical laboratories (aside from advanced diagnostic

laboratory tests, for which PAMA also altered payment, coding, and coverage) about private

payer payment rates beginning in 2016. The new payment system was to be phased in from 2017

through 2022; during the phase-in period, payment could not be reduced, compared with the

amount of the payment in the preceding year, by more than a statutorily specified limit. For each

year 2017-2019, the CLFS payment reduction limit was to be 10%, and for each year 2020-2022,

the payment reduction limit was to be 15%. Beginning in 2018, CMS set CLFS rates based on the

weighted median of private payer rates for each laboratory service, collected from applicable

laboratories. These CLFS payment rates are national and do not vary based on geography.

Section 105 of the Further Consolidated Appropriations Act of 2020 (P.L. 116-94) modified the

schedule for implementing the new CLFS payment system and reporting requirements. A period

during which there would be no reporting required from diagnostic laboratories was established,

from January 1, 2020, through December 31, 2020. The first required reporting period would

begin January 1, 2021, and end March 31, 2021, with subsequent reporting periods required every

three years thereafter. The phase-in schedule was modified so that the payment reduction limit

was to be 10% for each year from 2017 through 2020, with the limit to be 15% from 2021

through 2023.

Provision

Section 3718 further delays the reporting requirements under the new CLFS payment

methodology and makes additional revisions to the payment reduction limits during the phase-in

schedule. The provision would extend the initial period during which no reporting is required

from the period beginning January 1, 2021, through December 31, 2021, with the first required

reporting period to begin on January 1, 2022, and end March 31, 2022. Subsequent required

reporting periods would occur every three years thereafter. For 2021, there would be no payment

reduction (i.e., 0% limit) during the phase-in of the private payer rate implementation schedule;

the payment reduction limit would be 15% for 2022 through 2024, when the private payer rate is

to be fully implemented.

Section 3719. Expansion of the Medicare Hospital Accelerated Payment Program

During the COVID-19 Public Health Emergency

Background

SSA Section 1815 permits the Secretary to make accelerated payments to an IPPS hospital and to

a Puerto Rico IPPS hospital that experiences significant cash flow problems.161 Cash flow

problems must arise out of one or more of the following: (1) a delay in Medicare payments, (2)

161 42 U.S.C. §1395g(e)(3).



exceptional situations beyond a hospital’s control that result in delayed billing, or (3) highly

exceptional situations where the Secretary deems an accelerated payment is appropriate. The

amount of the accelerated payment may not exceed 70% of the estimated unbilled charges or

unpaid bills (less deductibles and coinsurance). An accelerated payment must be paid-in-full

within 90 days after such payment is made. If an accelerated payment is not paid in full within 90

days, CMS is authorized to withhold Medicare payments until the accelerated payment is repaid.

Accelerated payments must be requested by a hospital, and those requests are reviewed and

approved by the appropriate CMS regional office.

Provision

Section 3719 amends SSA Section 1815 to expand eligibility for accelerated payments to Critical

Access Hospitals (CAHs), pediatric hospitals, and IPPS-exempt cancer hospitals located in one of

the 50 states or the District of Columbia, during the COVID-19 emergency period.162 The

expansion of accelerated payments made under this provision is subject to appropriate safeguards

against fraud, waste, and abuse. In addition, upon the request of a hospital that is eligible for

accelerated payment under this provision, the Secretary may implement the following

amendments during the designated public health emergency period: make accelerated payments

on a periodic or lump sum basis; increase payments by an amount up to 100% of the estimated

unbilled charges or unpaid bills or 125% for CAHs; and specify that the accelerated payments can

cover up to a six-month period of unbilled charges or unpaid bills. The Secretary is required to

extend the recoupment period up to 120 days upon request of the hospital. Also upon request, a

hospital is allowed no less than 12 months from the date of the first accelerated payment to pay in

full any outstanding balance. The Secretary may implement this provision through program

instruction or otherwise.

Section 3720. Delaying Requirements for Enhanced FMAP to Enable State

Legislation Necessary for Compliance

Background

Medicaid is jointly financed by the federal government and the states. The federal government’s

share of a state’s expenditures for most Medicaid services is called the FMAP rate, which varies

by state and is designed so that the federal government pays a larger portion of Medicaid costs in

states with lower per capita incomes relative to the national average (and vice versa for states

with higher per capita incomes).163 Exceptions to the regular FMAP rate have been made for

certain states, situations, populations, providers, and services.

In the past, two temporary FMAP exceptions were available to provide states with fiscal relief

due to recessions. They were provided through the Jobs and Growth Tax Relief Reconciliation

Act of 2003 (P.L. 108-27) and the American Recovery and Reinvestment Act of 2009 (P.L. 111-

5). To be eligible for both of these temporary FMAP increases, states had to abide by some

requirements. These requirements varied in the two FMAP increases, but for both increases, states

were required to maintain Medicaid “eligibility standards, methodologies, and procedures” and to

ensure that local governments did not pay a larger percentage of the state’s nonfederal Medicaid

expenditures than would have been required otherwise.

162 42 U.S.C. §1395x(mm) for Critical Access Hospitals (CAHs); 42 U.S.C. §1395ww(d)(1)(B)(3) for pediatric

hospitals; and 42 U.S.C. §1395ww(d)(1)(B)(v) for PPS-exempt cancer hospitals.

163 For more information about the federal medical assistance percentage, see CRS Report R43847, Medicaid’s Federal

Medical Assistance Percentage (FMAP).



Section 6008 of FFCRA provides an increase to the FMAP rate for all states, the District of

Columbia, and the territories of 6.2 percentage points for each calendar quarter occurring during

the period beginning on the first day of the public health emergency period (i.e., January 1, 2020)

and ending on the last day of the calendar quarter in which the last day of the public health

emergency period ends.

States, the District of Columbia, and the territories will not receive this FMAP rate increase if (1)

the Medicaid “eligibility standards, methodologies, or procedures” are more restrictive than what

was in effect on January 1, 2020;164 (2) the amount of premiums imposed by the state exceeds the

amount as of January 1, 2020; (3) eligibility is not maintained for individuals enrolled in

Medicaid on the date of FFCRA enactment (i.e., March 18, 2020) or for individuals who enroll

during the public health emergency period through the end of the month in which the public

health emergency period ends (unless the individual requests a voluntary termination of eligibility

or the individual ceases to be a resident of the state); or (4) the state does not provide coverage

(without the imposition of cost-sharing) for any testing services and treatments for COVID-19

(including vaccines, specialized equipment, and therapies).

Section 6008 of FFCRA also modifies SSA Section 1905(cc) to add another condition for the

FMAP rate increase. Specifically, states, the District of Columbia, and the territories cannot

require local governments to fund a larger percentage of the state’s nonfederal Medicaid

expenditures for the Medicaid state plan or Medicaid disproportionate share hospital payments

than what was required on March 11, 2020.

Provision

Section 3720 of the CARES Act amends Section 6008 of FFCRA to delay the application of the

requirement that a state cannot receive the increased FMAP rate if the amount of premiums

imposed by the state is higher than the amount imposed as of January 1, 2020. Specifically, the

application of the premium requirement is delayed for 30 days after March 18, 2020 (i.e., the date

of enactment for FFCRA). Effectively, a state will be eligible for the FFCRA FMAP increase

through April 17, 2020, if the amount of premiums imposed by the state exceeds the amount

imposed as of January 1, 2020, as long as the premiums were in effect on the date of enactment

for FFCRA. In order to receive the FMAP increase, a state still needs to be in compliance with all

of the other requirements listed in FFCRA.

Subtitle F—Over-the-Counter Drugs

Part I—OTC Drug Review

Background

FDA regulates the safety and effectiveness of nonprescription or OTC drugs sold in the United

States. Examples of OTC drugs include hand sanitizer, sunscreen, and certain analgesics. To

market an OTC drug, a company may follow one of two pathways. First, a company may submit

an NDA to FDA for approval. Second, a company may use the OTC drug monograph process. A

monograph establishes conditions—active ingredient(s) and related conditions (e.g., dosage level,

164 A similar provision was in place prior to FFCRA for Medicaid and the State Children’s Health Insurance Program

(CHIP) children. Under Social Security Act (SSA) Section 1902(gg)(2) and SSA Section 2105(d)(3), states are required

to maintain the Medicaid and CHIP eligibility standards, methodologies, and procedures for children in place on the

date of enactment of the ACA, through FY2027. The penalty to states for not complying with either the Medicaid or the

CHIP maintenance of effort requirements for children would be the loss of all federal Medicaid funds.



combination of active ingredients, labeled indications, warnings and adequate directions for

use)—under which an OTC drug in a given therapeutic category (e.g., sunscreen, antacid) is

considered generally recognized as safe and effective (GRASE) for use. If an OTC drug product

complies with a monograph, it does not need FDA approval of its NDA prior to marketing. Prior

to enactment of the CARES Act, monographs were established and amended through rulemaking.

FDA assesses monograph compliance as part of its inspection process.165

The OTC drug monograph program—established in 1972—was intended to provide an efficient

mechanism through which OTC drugs could be marketed without individual FDA evaluation and

approval. However, the program has been met with several challenges. For example, some

monographs remain unfinalized, so there are OTC drugs on the market without final safety and

effectiveness determinations. There are also perceived limitations to the industry’s ability to

propose innovations to currently marketed OTC drugs without submitting an NDA, and FDA has

stated that it has limited resources to support OTC monograph activities.166

Section 3851. Regulation of Certain Nonprescription Drugs that Are Marketed

Without an Approved Drug Application

Provision

Section 3851 establishes a new FFDCA Section 505G, which replaces the current OTC drug

monograph rulemaking process with the administrative order process—a less burdensome

alternative. This new process allows FDA, on its own initiative or upon request, to issue an

administrative order (rather than a rule) determining that a drug, or class or combination of drugs,

is GRASE or not GRASE. Certain monograph changes (e.g., new active ingredient, new

indication) that are industry-requested and subject to a final administrative order are eligible for

18 months of marketing exclusivity. New FFDCA Section 505G, among other things, also (1)

requires that certain OTC drugs be marketed only pursuant to FDA approval via an NDA; (2)

creates an expedited process for the issuance of administrative orders in certain circumstances

(i.e., public health hazard, safety labeling changes); (3) provides for circumstances under which

minor changes in dosage form can be made without a new administrative order; (4) requires FDA

to publish on its website information related to final interim and administrative orders, develop

guidance, and establish meeting procedures; and (5) requires GAO to conduct a study on the

impact of the 18-month marketing exclusivity period for certain eligible OTC drugs.

Section 3852. Misbranding

Section 3852 amends FFDCA Section 502 to deem a drug misbranded if it is an OTC monograph

drug that is subject to new FFDCA Section 505G, is not the subject of an approved NDA or

ANDA, and does not comply with the requirements in FFDCA Section 505G. This provision also

deems a drug misbranded if it is “manufactured, prepared, propagated, compounded, or

processed” in a facility for which OTC monograph user fees have not been paid.

165 For additional information, see CRS In Focus IF10463, Regulation of Over-the-Counter (OTC) Drugs.

166 Testimony from Janet Woodcock, M.D., on Modernizing FDA’s Regulation of Over-The-Counter Drugs before

House Committee on Energy and Commerce, September 13, 2017, https://www.fda.gov/news-events/congressional-

testimony/modernizing-fdas-regulation-over-counter-drugs.



Section 3853. Drugs Excluded from the Over-The-Counter Drug Review

Section 3853 states that nothing in this act (or the amendments made by it) applies to any OTC

drug excluded by FDA from the OTC Drug Review in accordance with the statement set out at 37

FR 9466 published on May 11, 1972.

Section 3854. Treatment of Sunscreen Innovation Act

Background

Some industry stakeholders and members of Congress perceived FDA to be delaying consumer

access to new sunscreens that were not originally included in the OTC Drug Review, and in

November 2014, the Sunscreen Innovation Act (SIA; P.L. 113-195) was enacted. The SIA—

codified in FFDCA Chapter V Subchapter I—created a new pathway for establishing whether

certain OTC sunscreen active ingredients (i.e., those marketed in the United States after 1972 or

those without any U.S. marketing experience) are GRASE. The SIA requires FDA to make

GRASE determinations in the form of administrative orders (first proposed orders and then final

orders) rather than through rulemaking, among other things.167 FDA has not yet approved any

submissions for new sunscreen through the SIA process, requesting that sponsors submit

additional safety and effectiveness data.

Provision

Section 3854 allows the sponsor of an OTC sunscreen active ingredient that is subject to a

proposed sunscreen order under the SIA to elect to transition into the review process under new

FFDCA Section 505G. The sponsor must notify FDA of such decision within 180 days of

enactment, as specified. Otherwise, the order must continue to be reviewed under the SIA. Final

sunscreen orders issued under the SIA are deemed final administrative orders under FFDCA

Section 505G. Certain final sunscreen orders issued under new FFDCA Section 505G are eligible

for 18 months of marketing exclusivity. Section 3854(b)(4) adds new FFDCA Section 586H,

which sunsets FFDCA Chapter V Subchapter I (added by the SIA) at the end of FY2022.

Section 3855. Annual Update to Congress on Appropriate Pediatric Indication

for Certain OTC Cough and Cold Drugs

Background

Between 2004 and 2005, more than 1,500 children under two years of age were treated in U.S.

emergency departments for adverse events associated with cough and cold medications.168

Concerns also arose regarding the use of these products in children under six years of age.169 In

October 2007, FDA convened the Joint Meeting of the Nonprescription Drugs Advisory

Committee and the Pediatric Advisory Committee “to discuss the safety and efficacy of [OTC]

cough and cold products marketed for pediatric use.”170 The committees determined that the

167 FDA, Guidance for Industry, “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process,” October


168 FDA, “Use Caution When Giving Cough and Cold Products to Kids,” https://www.fda.gov/drugs/special-features/

use-caution-when-giving-cough-and-cold-products-kids.

169 Citizen Petition to FDA from the Baltimore City Health Department et al., March 1, 2007, Docket ID FDA-2007-P-

0050-0023.

170 FDA, Center for Drug Evaluation and Research (CDER), “Joint meeting of the Nonprescription Drugs Advisory

Committee and the Pediatric Advisory Committee,” Agenda, October 18 and 19, 2007, http://wayback.archive-it.org/



available published studies did not demonstrate that OTC monograph cough and cold products

marketed for pediatric use were effective in children and recommended additional studies and

labeling changes.171 To date, FDA has not amended the monograph for these products in 21

C.F.R. Part 341 to reflect the committee recommendations. Absent rulemaking, FDA has issued

several consumer updates warning of potential harms associated with the use of certain cough and

cold drug products in children. Manufacturers voluntarily removed OTC infant cough and cold

products intended for children under two years of age and voluntarily updated product labeling to

include the warning “do not use in children under 4 years of age.”172 However, such labeling

changes are not required by FDA under the cough and cold monograph, and in order for FDA to

require such labeling for these products, the agency would have to amend the monograph.

Provision

Section 3855 requires that, not later than one year after enactment and annually thereafter until

FDA completes its evaluation, the Secretary submits to the Senate HELP and House Energy and

Commerce committees a letter describing FDA’s progress in (1) evaluating the cough and cold

monograph under 21 C.F.R. Part 341 with respect to children under age six and (2) as appropriate,

revising the monograph to address children under age six, through the administrative order

process under new FFDCA Section 505G(b).

Part II—User Fees

Section 3862. Fees Relating to Over-The-Counter Drugs

Background

Historically, OTC drug monograph activities have been funded solely by discretionary

appropriations from the General Fund of the Treasury. This funding method is in contrast to

FDA’s prescription drug activities, which are funded by a combination of discretionary

appropriations and industry-paid user fees. This is because in 1992, the Prescription Drug User

Fee Act (PDUFA) gave FDA the authority to collect fees from the pharmaceutical industry and

use the revenue to support “the process for the review of human drug applications.”173 PDUFA

connected the user fees to performance goals that were negotiated between FDA and industry.

The five-year PDUFA authority has been renewed on five subsequent occasions, and user fee

authorities have been added for medical devices, animal drugs, tobacco products, and other FDA-

regulated products and activities. These fee authorities—codified in FFDCA Chapter VII,

Subchapter C—allow the Secretary, acting through the FDA Commissioner, to assess, collect, and

spend user fees paid from regulated entities for specified FDA activities.

Provision

Section 3862 creates in FFDCA Chapter VII, a new Part 10—“Fees Relating to Over-The-

Counter Drugs”—and the following new FFDCA sections: Section 744L (“Definitions”), Section

744M (“Authority to Assess and Use OTC Monograph Fees”), and Section 744N

7993/20170404050512/https://www.fda.gov/ohrms/dockets/ac/07/agenda/2007-4323a1-Final.pdf.

171 Meeting minutes, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory

Committee October 18-19, 2007, http://wayback.archive-it.org/7993/20170404050526/https://www.fda.gov/ohrms/

dockets/ac/07/minutes/2007-4323m1-Final.pdf.

172 FDA, “Use Caution When Giving Cough and Cold Products to Kids,” https://www.fda.gov/drugs/special-features/

use-caution-when-giving-cough-and-cold-products-kids.

173 P.L. 102-571.



(“Reauthorization; Reporting Requirements”). New FFDCA Section 744M establishes a legal

framework for the Secretary, beginning with FY2021, to assess and collect facility fees and

monograph order request fees to support FDA’s OTC monograph drug activities (e.g., review of

order requests, inspections). Fees may be collected and spent only to the extent and in the amount

provided in advance in appropriations acts (with an exception for the first year of the program),

may remain available until expended, and may be transferred as specified for monograph drug

activities only. This user fee program is authorized through FY2025. New FFDCA Section 744N

requires the Secretary to submit annual performance and fiscal reports on user fee collection and

spending to the Senate HELP and House Energy and Commerce committees. The performance

and fiscal reports must be made publicly available on FDA’s website. New FFDCA Section 744N

also specifies the process for reauthorization of the user fee program, requiring the Secretary to

consult with stakeholders on recommendations for future monograph activities and to transmit the

recommendations to Congress no later than January 15, 2025.



Appendix. Health Provisions in Title III of the

CARES Act: Implementation Dates, Reporting

Requirements, and Deadlines The table below includes relevant provisions (listed in order number) that include an effective

date, a required report, or an explicit sunset date. The table does not include every provision

described in this report, nor does it include required internal reports (i.e., reports required by

grantees); it includes only reports that must be made public or be delivered to Congress. This

CRS report reflects the CARES Act at enactment and will not be track actions pursuant to these

deadlines, nor will this report be updated.

CRS-61

Table A-1. Title III CARES Act Provisions with Implementation Dates, Reporting Requirements, and Deadlines

Provision Number Title Brief Description Effective Date/Reporting Deadlines

Section 3101 National Academies Report on

America’s Medical Product Supply Chain

Security

Requires the Secretary to enter into an

agreement with NASEM to examine and

report on the security of the U.S.

medical product supply chain.

Not later than 60 days after enactment

(i.e., by May 26, 2020).

Section 3112 Additional Manufacturer Reporting

Requirements In Response to Drug

Shortages

Requires the Secretary to transmit to

CMS a report regarding the drugs on

the current drug shortage list.


(i.e., by September 23, 2020) and every

90 days thereafter, including Section

3111 amendments) effective 180 days

after enactment (i.e., by September 23,

2020).

Section 3212 Telehealth Network and Telehealth

Resource Centers Grant Programs

Requires the Secretary to submit a

report, to specified congressional

committees, on the activities and

outcomes of the Telehealth Network

Grant Program and the Telehealth

Resource Centers Program.

Not later than four years after

enactment (i.e., by March 27, 2024) and

every five years thereafter.

Section 3213 Rural Health Care Services Outreach, Rural Health Network Development,

and Small Health Care Provider Quality

Improvement Grant Programs

Requires the Secretary to submit a report, to specified congressional

committees, on the activities and

outcomes of the specified rural health

related grant programs.

Not later than four years after enactment (i.e., by March 27, 2024) and

every five years thereafter.

Section 3215 Limitation on Liability for Volunteer

Health Care Professionals During

COVID-19 Emergency Response

Section confers medical malpractice

liability on health professionals who

volunteer during the emergency period.

Liability coverage is effective at

enactment (i.e., March 27, 2020),

through the duration of the public

health emergency, when the coverage

protections sunset.

Section 3221 Confidentiality and Disclosure of

Records Relating to Substance Use

Disorder

Requires the Secretary to revise

regulations as necessary to better align

the HIPAA Privacy Rule requirements

with those for substance use disorder

records under PHSA Section 543 to

facilitate improved patient care and care

coordination.

Changes apply to use and disclosures of

covered records occurring on or after

the date that is 12 months after

enactment (i.e., by March 27, 2021).

CRS-62


Section 3221 Confidentiality and Disclosure of

Records Relating to Substance Use

Disorder

Requires the Secretary, in consultation

with specified experts, to update the

notice of privacy practices requirement

in the HIPAA Privacy Rule to require

covered entities and entities creating or

maintaining covered records to provide

notice, in plain language, of privacy

practices regarding those records.

Not later than one year after enactment

(i.e., by March 27, 2021).

Section 3224 Guidance on Protected Health

Information

Requires the Secretary to issue guidance

with respect to sharing patients’

protected health information during the

COVID-19 public health emergency,

and specifically clarifying compliance

with HIPAA Privacy Rule requirements

and related policies.


(i.e., by September 23, 2020).

Section 3225 Reauthorization of Healthy Start

Program

Requires GAO to conduct an

independent evaluation of the Healthy

Start program and to submit a report to

specified congressional committees that

contains a review, an assessment, and

recommendations on a number of

specified topics regarding the Healthy

Start Program and the allocation of

funding provided under the program.



Section 3226 Importance of the Blood Supply Requires the Secretary to submit a

report to specified congressional

committees that (1) describes the

awareness activities carried out under

this section, (2) describes trends in

blood supply donations, and (3)

evaluates the impact of the public

awareness campaign.

Not later than two years after


CRS-63


Section 3301 Removing the Cap on OTA During

Public Health Emergencies



committees on use of this other

transaction authority including the

reasons for using it and any outcomes,

benefits, and risks associated with its

use.

After the expiration of the public health

emergency (which began January 31,

2020).

Section 3401 Reauthorization of Health Professions

Workforce Programs

Requires the Secretary to report to

specified congressional committees on

certain specified elements related to

health workforce diversity programs

that provide scholarships, loans, and

educational assistance.

Not later than September 30, 2023, and

not less than every five years thereafter.

Section 3402 Health Workforce Coordination Requires the Secretary, in consultation

with specified entities, to develop a

comprehensive plan to coordinate

HHS’s health care workforce

development programs.

Not later than one year after enactment

(i.e., by March 27, 2021).

Section 3402 Health Workforce Coordination Requires the Secretary to report to

specified congressional committees

about the implementation of the HHS’s

plan to coordinate its health care

workforce development programs.

Not later than two years after


Section 3403 Education and Training Relating to

Geriatrics



committees that describes certain

specified elements of funded geriatric

workforce programs.


enactment of the Title VII Health Care

Workforce Reauthorization Act of 2019

and every five years thereafter.a

Section 3404 Nursing Workforce Development Requires the Secretary to submit a


committees on nursing workforce

program improvements.

Not later than September 30, 2020, and

biennially thereafter.

CRS-64


Section 3404 Nursing Workforce Development Requires a GAO report delivered to

certain specified congressional

committees that evaluates nursing

workforce loan repayment programs.

Not later than 18 months after

enactment (i.e., by September 27, 2021).

Section 3701 Exemption for Telehealth Services Amends the IRC, applicable for plan

years beginning on or before December

31, 2021, to allow health savings

account (HSA)-qualified high-deductible

health plans to provide “telehealth and

other remote care service” benefits

before the deductible is met.

Effective upon enactment (i.e., March

27, 2020).

Section 3701 Exemption for Telehealth Services Amends the IRC, for plan years

beginning on or before December 31,

2021, to provide that telehealth and

other remote care would not be

considered disqualifying coverage that

would prevent an otherwise eligible

individual from being considered HSA-

eligible.


27, 2020).

Section 3702 Inclusion of Certain Over-The-Counter

Medical Products as Qualified Medical

Expenses

Amends the IRC to allow OTC over-

the-counter medicines and drugs

(without a prescription) and menstrual

care products to be considered qualified

medical expenses for HSAs, Archer

medical savings accounts, flexible

spending arrangements, and health

reimbursement arrangements.

Distributions from savings accounts:

Applied to amounts paid after

December 31, 2019.

Reimbursements: Applied to expenses

incurred after December 31, 2019.

Section 3708 Improving Care Planning for Medicare

Home Health Services

Amends the SSA to allow a nurse

practitioner, clinical nurse specialist, or

physician assistant to certify the

eligibility requirements for Medicare

home health services under Parts A

and B.

Effective no later than six months after

enactment (i.e., by September 27, 2020).

CRS-65


Section 3712 Revising Payment Rates for Durable

Medical Equipment Under the Medicare

Program through Duration of

Emergency Period

Requires the Secretary to increase the

Medicare payments for certain durable

medical equipment, prosthetics,

orthotics and supplies provided in areas

that are not rural, and are contiguous.

Effective from the date that is 30 days

after the enactment of the CARES Act

(i.e., April 26, 2020) through the end of

the emergency period.

Section 3713 Coverage of the COVID-19 Vaccine

Under Part B of the Medicare Program

Without Any Cost-Sharing

Medicare Part B and MA are required to

cover a COVID-19 vaccine and its

administration without beneficiary cost-

sharing or application of the annual Part

B deductible.


27, 2020) and applicable to a COVID-19

vaccine on the date it receives FDA

approval.

Section 3716 Clarification Regarding Uninsured

Individuals

Amends the definition of uninsured

individuals for the purposes of

determining Medicaid eligibility for the

state plan option to allow for time-

limited COVID-19 testing without cost-

sharing.

Effective during any portion of the

public health emergency period defined

in section 1135(g)(1)(B) of the act

beginning on or after March 18, 2020.

Section 3717 Clarification Regarding Coverage of

COVID-19 Testing Products

Modifies the definition of COVID-19

tests covered under Medicaid and CHIP

for the specified public health

emergency period to include IVDs, as

defined in FDA regulation, which detect

SARS-CoV-2 or diagnose COVID-19.

Effective during any portion of the

public health emergency period defined

in section 1135(g)(1)(B) of the act

beginning on or after March 18, 2020.

Section 3718 Amendments Relating to Reporting

Requirements with Respect to Clinical

Diagnostic Laboratory Tests

Delays reporting requirements and

phase-in schedule changes to the

Medicare Clinical Laboratory Fee

Schedule.

Delays reporting requirements by one

year (initial reporting to begin January 1,

2022 and end March 31, 2022.)

[Implementation schedule modified,

with no payment reductions for 2021

and 15% limit on reductions in 2022

through 2024.]

Section 3851 Regulation of Certain Nonprescription

Drugs that are Marketed Without an

Approved Drug Application

Requires GAO to submit to Congress a

study on the 18-month exclusivity

period established by this act, including

the impact of such exclusivity on

consumer access to OTC drugs and

other specified information.



CRS-66


Section 3854 Treatment of the Sunscreen Innovation

Act (SIA)

Sunsets FFDCA Chapter V Subchapter I

“Nonprescription Sunscreen and Other

Active Ingredients” (established by the

SIA).

Sunsets at the end of FY2022.

Section 3854 Treatment of the Sunscreen Innovation

Act

Requires the Secretary to amend and

revise the final administrative order

concerning OTC sunscreen (currently

under 21 C.F.R. Part 352). If the revised

sunscreen order does not include

certain information (e.g., effective SPF

levels), then the Secretary must submit

to Congress a report with the rationale

for not including it and a plan to

compile the necessary information.

Not later than 18 months after

enactment (i.e., by September 27, 2021)

and issued by the Secretary at least one

year prior to the effective date of the

revised order. No specified date for the

report.

Section 3855 Annual Update to Congress on

Appropriate Pediatric Indication for

Certain OTC Cough and Cold Drugs

Requires the Secretary to submit to

Congress a letter describing FDA’s

progress in evaluating the cough and

cold monograph under 21 C.F.R. Part

341 with respect to children under age

six and, as appropriate, revising the

monograph to address this age group.

Annually, beginning not later than one

year after enactment (i.e., by March 27,

2021), until FDA completes its

evaluation.

Section 3862 Fees Relating to Over-The-Counter

Drugs

Requires the Secretary to establish

OTC monograph drug facility fees for

FY2021 and subsequent years and to

publish fee revenue, facility fees, and

OTC monograph order request fees in

the Federal Register.

For FY2021, not later than the second

Monday in May 2020 (i.e., by May 11,

2020) and for every subsequent fiscal

year after September 30, 2021, not later

than the second Monday in March that

precedes such fiscal year.

Source: Table prepared by the Congressional Research Service (CRS) based on statutory language contained in Title III of the CARES Act (P.L. 116-136).

Notes: CARES Act=Coronavirus Aid, Relief, and Economic Security Act; C.F.R=Code of Federal Regulations; CMS = Centers for Medicare and Medicaid Services;

FDA=Food and Drug Administration; FFDCA= Federal Food, Drug, and Cosmetic Act; FY=Fiscal Year; GAO=Government Accountability Office; HHS = Department of

Health and Human Services; HIPAA= Health Insurance Portability and Accountability Act; HSA=Health Savings Account; IRC=Internal Revenue Code; MA=Medicare

Advantage; NASEM=National Academies of Science, Engineering, and Medicine; OTA=Other Transaction Authority; OTC=Over-The-Counter; Secretary=Secretary of

the Department of Health and Human Services (HHS); SIA=Sunscreen Innovation Act; SSA=Social Security Act.

CRS-67

a. The reference to the Title VII Health Care Workforce Reauthorization Act of 2019 appears to be a drafting error. However, this provision was included, with

changes to the authorization date and amounts, in the Title VII Health Care Workforce Reauthorization Act of 2019. See version of S. 2997, as reported to the

Senate on December 17, 2019.



Author Information

Elayne J. Heisler, Coordinator

Specialist in Health Services

Sarah A. Lister

Specialist in Public Health and Epidemiology

Evelyne P. Baumrucker

Specialist in Health Care Financing

Suzanne M. Kirchhoff

Analyst in Health Care Financing

Cliff Binder


Isaac A. Nicchitta

Research Assistant

Kirsten J. Colello

Specialist in Health and Aging Policy

Paulette C. Morgan


Agata Dabrowska

Analyst in Health Policy

Alison Mitchell


Patricia A. Davis


Ryan J. Rosso


Victoria L. Elliott


Amanda K. Sarata

Specialist in Health Policy

Vanessa C. Forsberg


Kavya Sekar


Frank Gottron

Specialist in Science and Technology Policy

Jared S. Sussman


Victoria R. Green


Marco A. Villagrana


Jim Hahn


Phoenix Voorhies


Noah D. Isserman

Analyst in Health Insurance and Financing


Congressional Research Service R46334 · VERSION 3 · NEW 69

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